General Diagnostics
Mchenry, IL, US
General Diagnostics appears in FDA device records in Mchenry, IL. FDA records list 39 510(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
- 39
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 39 510(k) clearances for General Diagnostics between 1976 and 1988. The busiest year on record is 1979, with 7. The most recent is 1988, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1977 | 2 |
| 1978 | 2 |
| 1979 | 7 |
| 1980 | 5 |
| 1981 | 4 |
| 1982 | 5 |
| 1983 | 6 |
| 1984 | 2 |
| 1987 | 4 |
| 1988 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K882663 | BARBITURATE ENZYME IMMUNOASSAY KIT | DIS | Substantially Equivalent | |
| K872882 | CANNABINOID ENZYME IMMUNOASSAY KIT | LDJ | Substantially Equivalent | |
| K871305 | COCAINE METABOLITE ENZYME IMMUNOASSAY KIT | DIO | Substantially Equivalent | |
| K864993 | QUALI. ENZYME IMMUNO. OF BARBITURATES IN URINE | DIS | Substantially Equivalent | |
| K863877 | BENZODIAZEPINE ENZYME IMMUNOASSAY KIT | JXM | Substantially Equivalent | |
| K842307 | GENERAL DIAG. CEFONICID 30MCG ANTIMIC | JTN | Substantially Equivalent | |
| K841465 | GENERAL DIAGNOSTICS PLATELET ANTIBODY | LLG | Substantially Equivalent | |
| K833709 | CEFTIZOXIME 30 MCG ANTIMICROBIAL DISK | JTN | Substantially Equivalent | |
| K832653 | CEFUROXIME 30MCG. SUSCEP DISK | JTN | Substantially Equivalent | |
| K831179 | CEFAZOLIN 30MCG. ANTIMICROBIAL SUSCEP | JTN | Substantially Equivalent | |
| K830731 | NETILMICIN 30 MCG ANTIMICROBIAL DISK | JTN | Substantially Equivalent | |
| K823453 | VON WILLEBRAND FACTOR ASSAY | GGP | Substantially Equivalent | |
| K823794 | CONTROL TM 8 | GLQ | Substantially Equivalent | |
| K822809 | AZLOCILLIN 75 MCG SUSCEPTIBILITY DISC | JTN | Substantially Equivalent | |
| K821229 | CEFOPERAZONE 75MCG. ANTIMICROBIAL DISK | JTN | Substantially Equivalent | |
| K820468 | PROFILE GENERAL SET ASSAYED SERUM CONTR | DIF | Substantially Equivalent | |
| K820019 | PIPERACILLIN 100MCG. ANTIMICROBIAL | JTN | Substantially Equivalent | |
| K813564 | COAG-A-MATE X2 | GKP | Substantially Equivalent | |
| K812994 | MINOCYCLINE 30MCG ANTIMICROBIAL SUS. DSK | JTN | Substantially Equivalent | |
| K812993 | MOXALACTOM 30MCG ANTIMICROBIAL SUS. DISK | JTN | Substantially Equivalent | |
| K812916 | MEZLOCILLIN 75MCG ANTIMICROB. SUSCEPT. D | JTN | Substantially Equivalent | |
| K812783 | TRIMETHOPRIM 5MCG. ANTIMICROBIAL DISK | JTN | Substantially Equivalent | |
| K803039 | PROFILE ANTI-CONVUL. SET ASSAYED S. CTL. | DIF | Substantially Equivalent | |
| K803036 | PROFILE CARDIAC SET ASSAYED SERUM CONTR. | DIF | Substantially Equivalent | |
| K802117 | FIBRI QUIK | GJA | Substantially Equivalent | |
| K800925 | VERIFY S PROD. #34141 | GGW | Substantially Equivalent | |
| K800926 | THROMBOQUIK THROMBIN REAGENT PROD. #3551 | GJA | Substantially Equivalent | |
| K792480 | CHEM-STRATE TRIGLYCERIDE | CDT | Substantially Equivalent | |
| K792479 | CHEM-STRATE AMYLASE | CIJ | Substantially Equivalent | |
| K792478 | CHEM-STRATE CHOLESTEROL | CHH | Substantially Equivalent | |
| K792477 | CHEM-STRATE CK-NAC | CGS | Substantially Equivalent | |
| K790372 | H-D-EL | LBR | Substantially Equivalent | |
| K790323 | COAG-A-MATE 2001 | JPA | Substantially Equivalent | |
| K781781 | HEPARSORB | GJA | Substantially Equivalent | |
| K781814 | SULFATE, FIBRIQUIK PROTAMINE | JBN | Substantially Equivalent | |
| K780285 | SOLUBLE COLLAGEN | JOZ | Substantially Equivalent | |
| K772106 | PH CALIBRATION BUFFERS | JIT | Substantially Equivalent | |
| K761250 | SIMPLATE | JCA | Substantially Equivalent | |
| K760790 | MICRO-ID | JSS | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- JITCalibrator, Secondary
- JCADevice, Bleeding Time
- DIFDrug Mixture Control Materials
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- DISEnzyme Immunoassay, Barbiturate
- JXMEnzyme Immunoassay, Benzodiazepine
- LDJEnzyme Immunoassay, Cannabinoids
- DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
- JBNFibrin Monomer Paracoagulation
- GKPInstrument, Coagulation, Automated
- JSSKit, Identification, Enterobacteriaceae
- LLGKit, Igg, Platelet Associated
- LBRLdl & Vldl Precipitation, Hdl
- CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- GLQMixture, Control, White-Cell And Red-Cell Indices
- CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
- CIJSaccharogenic, Amylase
- JTNSusceptibility Test Discs, Antimicrobial
- JOZSystem, Automated Platelet Aggregation
- JPASystem, Multipurpose For In Vitro Coagulation Studies
- GGPTest, Qualitative And Quantitative Factor Deficiency
- GJATest, Thrombin Time
- GGWTest, Time, Partial Thromboplastin
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain
