Roche Diagnostic Systems, Inc.
Mchenry, IL, US
Roche Diagnostic Systems, Inc. appears in FDA device records in Mchenry, IL. FDA records list 296 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 296
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 296FDA records hold 296 510(k) clearances for Roche Diagnostic Systems, Inc. between 1983 and 1999. The busiest year on record is 1991, with 40. The most recent is 1999, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1983 | 1 |
| 1984 | 8 |
| 1985 | 23 |
| 1986 | 2 |
| 1987 | 21 |
| 1988 | 10 |
| 1989 | 29 |
| 1990 | 37 |
| 1991 | 40 |
| 1992 | 14 |
| 1993 | 24 |
| 1994 | 18 |
| 1995 | 20 |
| 1996 | 16 |
| 1997 | 10 |
| 1998 | 20 |
| 1999 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K983698 | MODIFICATION TO ABUSCREEN ONLINE BARBITURATES | DIS | Substantially Equivalent | |
| K983702 | MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINES | JXM | Substantially Equivalent | |
| K983704 | MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE | JCM | Substantially Equivalent | |
| K983556 | ABUSCREEN ONLINE BENZ 300 CALIBRATORS | DLJ | Substantially Equivalent | |
| K983555 | ABUSCREEN ONLINE BENZ 200 CALIBRATORS | DLJ | Substantially Equivalent | |
| K983703 | MODIFICATION TO ABUSCREEN ONLINE FOR METHADONE | DJR | Substantially Equivalent | |
| K983701 | MODIFICATION TO ABUSCREEN ONLINE FOR CANNABINOIDS | LDJ | Substantially Equivalent | |
| K983700 | MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE | JXN | Substantially Equivalent | |
| K983699 | MODIFICATION TO ABUSCREEN ONLINE FOR AMPHETAMINES | DKZ | Substantially Equivalent | |
| K983697 | MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE | DIO | Substantially Equivalent | |
| K983388 | ONTRAK TESTCUP-ER | DIO | Substantially Equivalent | |
| K983174 | ONTRAK TESTSTIK FOR BARBITURATES, ONTRAK TESTSTIK FOR BENZODIAZEPINES | JXM | Substantially Equivalent | |
| K983387 | ONTRAK TESTCUP AND TESTSTIK CONTROLS | DIF | Substantially Equivalent | |
| K982848 | COBAS INTEGRA LDL DIRECT REAGENT CASSETTE ROCHE CALIBRATOR LDL DIRECT | MRR | Substantially Equivalent | |
| K982382 | COBAS INTEGRA REAGENT CASSETTES | CFN | Substantially Equivalent | |
| K981897 | ROCHE COBAS INTEGRA ALKALINE PHOSPHATASE IFCC LIQUID REAGENT CASSETTE, ROCHE COBAS INTEGRA PANCREATIC A-AMYLASE EPS REAE | CJE | Substantially Equivalent | |
| K982551 | ROCHE C0BAS INTEGRA SERUM BARBITURATES REAGENT CASSETTE, ABUSCREEB ONLINE SERUM BARBITURATES CALIBRATORS, ROCHE COBAS IN | DIS | Substantially Equivalent | |
| K982087 | ROCHE CRP T CONTROL N | DCK | Substantially Equivalent | |
| K980996 | COBAS INTEGRA CARBON DIOXIDE (CO2-S), COBAS INTEGRA GLUCOSE HK LIQUID (GLULF) | KHS | Substantially Equivalent | |
| K981585 | ABUSCREEN ONLINE FOR CANNABINOIDS (1000 TEST KIT) | LDJ | Substantially Equivalent | |
| K981584 | ABUSCREEN ONLINE FOR CANNABINOIDS (100 TEST KIT) | LDJ | Substantially Equivalent | |
| K974695 | COBRAS INTEGRA ACID PROSTATIC PHOSPHATASE (ACPP) COBAD INTEGRA BENZODIAZEPINES WITH B-GLUCURONIDASE (BNZGL) | CKB | Substantially Equivalent | |
| K974840 | ABUSCREEN ONLINE II FOR OPIATES 300/2000, ABUSCREEN ONLINE OPIATES CALIBRATION PACK, ABUSCREEN ONLINE OPIATES CONTROL | DJG | Substantially Equivalent | |
| K973284 | COBAS INTEGRA HDL-CHOLESTEROL DIRECT | CHH | Substantially Equivalent | |
| K973369 | ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM) | LBR | Substantially Equivalent | |
| K973075 | ONTRAK TESTSTIK FOR AMPHETAMINES, ONTRAK TESTSTIK FOR COCAINE, ONTRAK TESTSTIK FOR MORPHINE, ONTRAK TESTSTIK FOR PCP, ON | DKZ | Substantially Equivalent | |
| K972891 | ABUSCREEN ONLINE FOR AMPHETAMINES WITH PERIODATE - OLYMPUS AU800/1000 INSTRUMENT APPLICATION | DKZ | Substantially Equivalent | |
| K972250 | ROCHE COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS | JFJ | Substantially Equivalent | |
| K972721 | ROCHE HEMOGLOBIN A1C CONTROL N AND CONTROL P | JJX | Substantially Equivalent | |
| K972214 | ROCHE SERUM CONTROL NORMAL (HUMAN), ROCHE SERUM CONTROL PATHOLOGICAL (HUMAN) | JJY | Substantially Equivalent | |
| K971902 | ROCHE UNIMATE HDL DIRECT REAGENT, ROCHE CALIBRATOR HDL DIRECT | LBS | Substantially Equivalent | |
| K964670 | ROCHE COBAS-FP REAGENTS FOR TOBRAMYCIN | LFW | Substantially Equivalent | |
| K964457 | ROCHE COBAS IBTEGRA REAGENT CASSETTES | JQB | Substantially Equivalent | |
| K964355 | ONTRAK TESTCUP 5 (MODIFICATION) | LCM | Substantially Equivalent | |
| K964422 | ONTRAK TESTTCUP COLLECTION/URINALYSIS PANEL | DIF | Substantially Equivalent | |
| K963292 | COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS | CIC | Substantially Equivalent | |
| K963627 | (MODIFIED VERSION) INTEGRA ION SELECTIVE ELECTRODE (ISE) MODULE | JGS | Substantially Equivalent | |
| K962411 | ONTRAK TESTCUP AMPHETAMINES | DKZ | Substantially Equivalent | |
| K961674 | ROCHE UNIMATE FRUCTOSAMINE REAGENT | LCP | Substantially Equivalent | |
| K962231 | COBAS CORE IMMUNOCHEMISTRY SYSTEM | JJE | Substantially Equivalent | |
| K962280 | ABUSCREEN ONLINE POSITIVE CONTROL / 1.5X CALIBRATOR | DLJ | Substantially Equivalent | |
| K961824 | COBAS INTEGRA REAGENT CASSETTES FOR ALBUMIN, HBALC AND DIGOXIN | DCF | Substantially Equivalent | |
| K961726 | ABUSCREEN ONLINE CANNABINOIDS CALIBRATION PACK 20 | DLJ | Substantially Equivalent | |
| K962165 | COBAS-FP TDM CALIBRATION VERIFICATION TEST SET | DIF | Substantially Equivalent | |
| K961436 | ABUSCREEN ONLINE LSD REAGENT (90 ML TEST KIT) | DLB | Substantially Equivalent | |
| K961620 | ABISCREEN ONLINE FOR CANNABINOIDS - ES 50/100 | LAT | Substantially Equivalent | |
| K953847 | ROCHE REAGENT FOR GLUCOSE | CFR | Substantially Equivalent | |
| K952337 | ROCHE UNIMATE 3/UNIMATE 5 HBA1C, HBA1C CALIBRATOR, HBA1C CONTROLS N & P | LCP | Substantially Equivalent | |
| K954992 | ROCHE COBAS INTEGRA REAGENT CASSETTES | CIT | Substantially Equivalent | |
| K954656 | ROCHE CONTROL SERUM P | JJY | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CKBAcid Phosphatase, Naphthyl Phosphate
- CDOAcid, Uric, Uricase (U.V.)
- DCFAlbumin, Antigen, Antiserum, Control
- DICAlcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
- CGXAlkaline Picrate, Colorimetry, Creatinine
- DERAlpha-1-Lipoprotein, Antigen, Antiserum, Control
- CJYAzo Dye, Calcium
- CEKBiuret (Colorimetric), Total Protein
- CIXBromcresol Green Dye-Binding, Albumin
- DCKC-Reactive Protein, Antigen, Antiserum, And Control
- DKBCalibrators, Drug Mixture
- DLJCalibrators, Drug Specific
- JFJCatalytic Methods, Amylase
- JHMColorimetric Method, Lipoproteins
- DKJColorimetry, Salicylate
- JCMControl, Hemoglobin, Abnormal
- CHSCoulometric Method, Carbon-Dioxide
- GKZCounter, Differential Cell
- CICCresolphthalein Complexone, Calcium
- CIGDiazo Colorimetry, Bilirubin
- DIFDrug Mixture Control Materials
- JGSElectrode, Ion Specific, Sodium
- CFEElectrophoretic, Lactate Dehydrogenase Isoenzymes
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- DKZEnzyme Immunoassay, Amphetamine
- DISEnzyme Immunoassay, Barbiturate
- DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
- DJREnzyme Immunoassay, Methadone
- DJGEnzyme Immunoassay, Opiates
- CGAGlucose Oxidase, Glucose
- DIWHemagglutination Inhibition, Methadone
- DLNHemagglutination, Cocaine Metabolites (Benzoylecgnonine)
- CFRHexokinase, Glucose
- CKDHydrazone Colorimetry, Alt/Sgpt
- CISHydrazone Colorimetry, Ast/Sgot
- DGCIge, Antigen, Antiserum, Control
- CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- CHJMercuric Thiocyanate, Colorimetry, Chloride
- CFNMethod, Nephelometric, Immunoglobulins (G, A, M)
- CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
- CFJNad Reduction/Nadh Oxidation, Lactate Dehydrogenase
- CKANadh Oxidation/Nad Reduction, Alt/Sgpt
- CITNadh Oxidation/Nad Reduction, Ast/Sgot
- CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- JGZO-Phthalaldehyde, Urea Nitrogen
- CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus
- JGJPhotometric Method, Magnesium
- DJPRadioimmunoassay, Amphetamine
- DPJRadioimmunoassay, Amphetamine (125-I), Goat Antibody, Ammonium Sulfate Sep.
- DKNRadioimmunoassay, Barbiturate
- CGJRadioimmunoassay, Follicle-Stimulating Hormone
- CECRadioimmunoassay, Free Thyroxine
- DLBRadioimmunoassay, Lsd (125-I)
- CEPRadioimmunoassay, Luteinizing Hormone
- DOERadioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.
- CFTRadioimmunoassay, Prolactin (Lactogen)
- CDPRadioimmunoassay, Total Triiodothyronine
- CIJSaccharogenic, Amylase
- GZIStimulator, Neuromuscular, External Functional
- CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain