Miles Laboratories, Inc.
Mchenry, IL, US
Miles Laboratories, Inc. appears in FDA device records in Mchenry, IL. FDA records list 158 510(k) clearances between and , 2 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
- 158
- PMA records
- 2
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 158FDA records hold 158 510(k) clearances for Miles Laboratories, Inc. between 1976 and 1988. The busiest year on record is 1980, with 30. The most recent is 1988, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 6 |
| 1977 | 15 |
| 1978 | 8 |
| 1979 | 7 |
| 1980 | 30 |
| 1981 | 19 |
| 1982 | 12 |
| 1983 | 18 |
| 1984 | 13 |
| 1985 | 10 |
| 1986 | 7 |
| 1987 | 10 |
| 1988 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K880605 | LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTER | FPB | Substantially Equivalent | |
| K874909 | MICRO-BUMINTEST REAGENT TABLETS | JIR | Substantially Equivalent | |
| K875079 | MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULE | CKA | Substantially Equivalent | |
| K871835 | GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINT | CGA | Substantially Equivalent | |
| K872120 | SERALYZER III BLOOD CHEMISTRY ANALYZER | JJF | Substantially Equivalent | |
| K873304 | CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES) | LJX | Substantially Equivalent | |
| K872634 | CUTTER PUREFLO PLUS IV FILTER | FPB | Substantially Equivalent | |
| K870214 | MODIFIED SALTEX REAGENT STRIPS | CHK | Substantially Equivalent | |
| K870752 | SERALYZER LDH/TOTAL BILIRUBIN/TRIGLYCERIDES STRIPS | CFJ | Substantially Equivalent | |
| K865053 | SERA-TEK MICROSOMAL ANTIBODY TEST | JZO | Substantially Equivalent | |
| K864530 | SERALYZER GLUCOSE (HK) REAGENT STRIPS,MODULE,CALI. | CGA | Substantially Equivalent | |
| K865020 | SERA-TEK THYROGLOBULIN ANTIBODY TEST | DDC | Substantially Equivalent | |
| K863842 | SERALYZER ARIS CARBAMAZEPINE STRIPS/MODU/CALI/CONT | KLT | Substantially Equivalent | |
| K861844 | GLUCOFACTS DATA MANAGEMENT SYSTEM | JQP | Substantially Equivalent | |
| K861779 | GLUCOFACTS DATA PRINTER | JQP | Substantially Equivalent | |
| K861778 | CLINIFACTS 200 DATA MANAGEMENT SYSTEM | JQP | Substantially Equivalent | |
| K861303 | GLUCOMETER II IMPROVED REFLECTANCE PHOTOMETER | CGA | Substantially Equivalent | |
| K855202 | GLUCOMETER M BLOOD GULCOSE METER | CGA | Substantially Equivalent | |
| K855203 | GLUCOLET AUTOMATIC LANCING DEVICE FOR OBT. BLOOD | FMK | Substantially Equivalent | |
| K855040 | SERALYZER TOTAL BILIRUBIN CALIBRATORS | JIS | Substantially Equivalent | |
| K852946 | SERA ARIS PHENO REAG STRIP, TEST MOD CAL & CLT | DLZ | Substantially Equivalent | |
| K852611 | TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINE | CDM | Substantially Equivalent | |
| K851703 | GLUCOSTIX REAGENT STRIPS & GLUCOMETER REFLECT-PHOT | CGA | Substantially Equivalent | |
| K852747 | VISIDEX II REAGENT STRIPS | Substantially Equivalent | ||
| K853021 | OPTIMATE DIGOXIN TEST | DPB | Substantially Equivalent | |
| K852117 | CYTO-TEK CENTRIFUGE | IFB | Substantially Equivalent | |
| K844955 | SERALYZER POTASSIUM REAGENT STRIPS, TEST MODULE, & | CEM | Substantially Equivalent | |
| K842092 | SERALYZER ARIS PHENYTOIN REAGENT STRIPS | DIP | Substantially Equivalent | |
| K844907 | CLINIFACTS 10 DATA MANAGEMENT SYSTEM | JQP | Substantially Equivalent | |
| K843727 | LEUKOSTIX REAGENT STRIPS FOR URINALYSIS | LJX | Substantially Equivalent | |
| K842470 | TISSUE-TEK IMMUNOHISTOLOGY KIT LYSOZZM | DFH | Substantially Equivalent | |
| K842468 | TISSUE-TEK IMMUNOHISTOLOGY KIT IGA/IGG | CZP | Substantially Equivalent | |
| K841041 | CLINI-TEK AUTO 2000 REFLECTANCE SPECTR | KQO | Substantially Equivalent | |
| K842592 | AMES TDA PHENOBARBITAL TEST | LET | Substantially Equivalent | |
| K842237 | CLINITEK 200 SEMI-AUTOMATED URINALYSIS | KQO | Substantially Equivalent | |
| K842238 | CLINITEK 10 SEMI-AUTO URINALYSIS SYS | KQO | Substantially Equivalent | |
| K842006 | CITOJECT CARTRIDGE SYRINGE | EJI | Substantially Equivalent | |
| K841816 | OPTIMATE IGG TEST | DEW | Substantially Equivalent | |
| K841814 | OPTIMATE IGM TEST | DFT | Substantially Equivalent | |
| K841815 | OPTIMATE IGA TEST | CZN | Substantially Equivalent | |
| K841582 | OPTIMATE DIGOXIN TEST | KXT | Substantially Equivalent | |
| K833977 | SERALYZER DRUG ASSAY CONTROL SERUM | DLJ | Substantially Equivalent | |
| K832825 | SERALYZER THEOPHYLLINE REAGENT STRIPS | KLS | Substantially Equivalent | |
| K832088 | AMES TDA NETILMICIN TEST & SERUM | LCE | Substantially Equivalent | |
| K832791 | SERAYZER ALT/SGPT REAGENT STRIPS | CKC | Substantially Equivalent | |
| K832790 | SERALYZER AST/SGOT REAGENT STRIPS | CIF | Substantially Equivalent | |
| K832684 | SERALYZER TRIGLYCERIDES REAGENT STRIPS | CDT | Substantially Equivalent | |
| K832792 | AMES TDA SISOMICIN TEST-CONTROL SERUM | DJB | Substantially Equivalent | |
| K832769 | AMES TDA KANAMYCIN TEST-CONTROL SERUM | KJI | Substantially Equivalent | |
| K832766 | AMES TDA DISOPYRAMIDE TEST | KLT | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CGXAlkaline Picrate, Colorimetry, Creatinine
- JJFAnalyzer, Chemistry, Micro, For Clinical Use
- GSBAntigens, Cf, All, Mycoplasma Spp.
- DHNAntinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
- CIXBromcresol Green Dye-Binding, Albumin
- JQPCalculator/Data Processing Module, For Clinical Use
- JIXCalibrator, Multi-Analyte Mixture
- JISCalibrator, Primary
- DLJCalibrators, Drug Specific
- FRFCleaner, Air, Medical Recirculating
- JJQColorimeter, Photometer, Spectrophotometer For Clinical Use
- JJJCounter (Beta, Gamma) For Clinical Use
- IFBCytocentrifuge
- CDMDiazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
- CEMElectrode, Ion Specific, Potassium
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- DIPEnzyme Immunoassay, Diphenylhydantoin
- DLFEnzyme Immunoassay, Ethosuximide
- DLZEnzyme Immunoassay, Phenobarbital
- DJDEnzyme Immunoassay, Primidone
- FPBFilter, Infusion Line
- CGAGlucose Oxidase, Glucose
- CZPIga, Antigen, Antiserum, Control
- CZNIga, Fitc, Antigen, Antiserum, Control
- DEWIgg, Antigen, Antiserum, Control
- DFTIgm, Antigen, Antiserum, Control
- JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)
- DFHKappa, Antigen, Antiserum, Control
- JSXKit, Identification, Neisseria Gonorrhoeae
- CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- CHKMercuric Nitrate And Diphenyl Carbazone (Titrimetric), Chloride
- JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)
- IDLMicrotome, Accessories
- IDOMicrotome, Rotary
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- DDRMyoglobin, Antigen, Antiserum, Control
- CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
- CFJNad Reduction/Nadh Oxidation, Lactate Dehydrogenase
- CKANadh Oxidation/Nad Reduction, Alt/Sgpt
- JINNitroprusside, Ketones (Urinary, Non-Quant.)
- JGZO-Phthalaldehyde, Urea Nitrogen
- IEOProcessor, Tissue, Automated
- GGKProducts, Red-Cell Lysing Products
- DPGRadioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Coated Tube Sep.
- DPBRadioimmunoassay, Digoxin (125-I), Rabbit Antibody, Charcoal Sep.
- DJBRadioimmunoassay, Gentamicin (125-I), Second Antibody Sep.
- JMFRadioimmunoassay, Human Placental Lactogen
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- CDXRadioimmunoassay, Total Thyroxine
- CDPRadioimmunoassay, Total Triiodothyronine
- JRERefractometer For Clinical Use
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
- EJISyringe, Cartridge
- JBDSystem, Analysis, Electrophoretic Hemoglobin
- DDCThyroglobulin, Antigen, Antiserum, Control
- JJWUrinalysis Controls (Assayed And Unassayed)
- CKCVanillin Pyruvate, Alt/Sgpt
- CIFVanillin Pyruvate, Ast/Sgot
- CIEVolumetric/Manometric, Carbon-Dioxide
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