Company ยท US
General Diagnostics
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1988. Name variants (Inc, Corp, punctuation) are merged.
39510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JTN | Susceptibility Test Discs, Antimicrobial | 12 |
| DIF | Drug Mixture Control Materials | 3 |
| GJA | Test, Thrombin Time | 3 |
| DIS | Enzyme Immunoassay, Barbiturate | 2 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 |
| CIJ | Saccharogenic, Amylase | 1 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 1 |
| GGP | Test, Qualitative And Quantitative Factor Deficiency | 1 |
| GGW | Test, Time, Partial Thromboplastin | 1 |
| GKP | Instrument, Coagulation, Automated | 1 |
| GLQ | Mixture, Control, White-Cell And Red-Cell Indices | 1 |
| JBN | Fibrin Monomer Paracoagulation | 1 |
| JCA | Device, Bleeding Time | 1 |
| JIT | Calibrator, Secondary | 1 |
| JOZ | System, Automated Platelet Aggregation | 1 |
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 1 |
| JSS | Kit, Identification, Enterobacteriaceae | 1 |
| JXM | Enzyme Immunoassay, Benzodiazepine | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 19, 1988 | K882663 | BARBITURATE ENZYME IMMUNOASSAY KIT General Diagnostics | DIS |
| Nov 3, 1987 | K872882 | CANNABINOID ENZYME IMMUNOASSAY KIT General Diagnostics | LDJ |
| Jun 5, 1987 | K871305 | COCAINE METABOLITE ENZYME IMMUNOASSAY KIT General Diagnostics | DIO |
| Mar 31, 1987 | K864993 | QUALI. ENZYME IMMUNO. OF BARBITURATES IN URINE General Diagnostics | DIS |
| Mar 12, 1987 | K863877 | BENZODIAZEPINE ENZYME IMMUNOASSAY KIT General Diagnostics | JXM |
| Jul 20, 1984 | K842307 | GENERAL DIAG. CEFONICID 30MCG ANTIMIC General Diagnostics | JTN |
| Jul 2, 1984 | K841465 | GENERAL DIAGNOSTICS PLATELET ANTIBODY General Diagnostics | LLG |
| Dec 30, 1983 | K833709 | CEFTIZOXIME 30 MCG ANTIMICROBIAL DISK General Diagnostics | JTN |
| Oct 14, 1983 | K832653 | CEFUROXIME 30MCG. SUSCEP DISK General Diagnostics | JTN |
| May 9, 1983 | K831179 | CEFAZOLIN 30MCG. ANTIMICROBIAL SUSCEP General Diagnostics | JTN |
| Apr 8, 1983 | K830731 | NETILMICIN 30 MCG ANTIMICROBIAL DISK General Diagnostics | JTN |
| Jan 21, 1983 | K823453 | VON WILLEBRAND FACTOR ASSAY General Diagnostics | GGP |
| Jan 14, 1983 | K823794 | CONTROL TM 8 General Diagnostics | GLQ |
| Nov 22, 1982 | K822809 | AZLOCILLIN 75 MCG SUSCEPTIBILITY DISC General Diagnostics | JTN |
| Jun 22, 1982 | K821229 | CEFOPERAZONE 75MCG. ANTIMICROBIAL DISK General Diagnostics | JTN |
| Mar 25, 1982 | K820468 | PROFILE GENERAL SET ASSAYED SERUM CONTR General Diagnostics | DIF |
| Jan 29, 1982 | K820019 | PIPERACILLIN 100MCG. ANTIMICROBIAL General Diagnostics | JTN |
| Jan 28, 1982 | K813564 | COAG-A-MATE X2 General Diagnostics | GKP |
| Dec 17, 1981 | K812994 | MINOCYCLINE 30MCG ANTIMICROBIAL SUS. DSK General Diagnostics | JTN |
| Nov 10, 1981 | K812993 | MOXALACTOM 30MCG ANTIMICROBIAL SUS. DISK General Diagnostics | JTN |
| Nov 6, 1981 | K812916 | MEZLOCILLIN 75MCG ANTIMICROB. SUSCEPT. D General Diagnostics | JTN |
| Oct 23, 1981 | K812783 | TRIMETHOPRIM 5MCG. ANTIMICROBIAL DISK General Diagnostics | JTN |
| Dec 22, 1980 | K803039 | PROFILE ANTI-CONVUL. SET ASSAYED S. CTL. General Diagnostics | DIF |
| Dec 22, 1980 | K803036 | PROFILE CARDIAC SET ASSAYED SERUM CONTR. General Diagnostics | DIF |
| Sep 26, 1980 | K802117 | FIBRI QUIK General Diagnostics | GJA |
| Jul 21, 1980 | K800925 | VERIFY S PROD. #34141 General Diagnostics | GGW |
| May 8, 1980 | K800926 | THROMBOQUIK THROMBIN REAGENT PROD. #3551 General Diagnostics | GJA |
| Dec 27, 1979 | K792480 | CHEM-STRATE TRIGLYCERIDE General Diagnostics | CDT |
| Dec 27, 1979 | K792479 | CHEM-STRATE AMYLASE General Diagnostics | CIJ |
| Dec 27, 1979 | K792478 | CHEM-STRATE CHOLESTEROL General Diagnostics | CHH |
| Dec 27, 1979 | K792477 | CHEM-STRATE CK-NAC General Diagnostics | CGS |
| May 3, 1979 | K790372 | H-D-EL General Diagnostics | LBR |
| Mar 21, 1979 | K790323 | COAG-A-MATE 2001 General Diagnostics | JPA |
| Jan 10, 1979 | K781781 | HEPARSORB General Diagnostics | GJA |
| Nov 8, 1978 | K781814 | SULFATE, FIBRIQUIK PROTAMINE General Diagnostics | JBN |
| Mar 30, 1978 | K780285 | SOLUBLE COLLAGEN General Diagnostics | JOZ |
| Dec 6, 1977 | K772106 | PH CALIBRATION BUFFERS General Diagnostics | JIT |
| Mar 1, 1977 | K761250 | SIMPLATE General Diagnostics | JCA |
| Oct 29, 1976 | K760790 | MICRO-ID General Diagnostics | JSS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||