General Diagnostics
Medical device manufacturer in Great Neck, NY.
39510(k) clearances
0PMA approvals
0recalls
Device types
- JTN Susceptibility Test Discs, Antimicrobial 12
- GJA Test, Thrombin Time 3
- DIF Drug Mixture Control Materials 3
- DIS Enzyme Immunoassay, Barbiturate 2
- CIJ Saccharogenic, Amylase 1
- LDJ Enzyme Immunoassay, Cannabinoids 1
- LLG Kit, Igg, Platelet Associated 1
- GGP Test, Qualitative And Quantitative Factor… 1
- GLQ Mixture, Control, White-Cell And Red-Cell… 1
- GKP Instrument, Coagulation, Automated 1
- GGW Test, Time, Partial Thromboplastin 1
- CDT Lipase Hydrolysis/Glycerol Kinase Enzyme… 1
- JSS Kit, Identification, Enterobacteriaceae 1
- CHH Enzymatic Esterase--Oxidase, Cholesterol 1
- CGS Nad Reduction/Nadh Oxidation, Cpk Or… 1
- LBR Ldl & Vldl Precipitation, Hdl 1
- JPA System, Multipurpose For In Vitro… 1
- JBN Fibrin Monomer Paracoagulation 1
- JOZ System, Automated Platelet Aggregation 1
- JIT Calibrator, Secondary 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K882663 | Barbiturate Enzyme Immunoassay KitDIS · Traditional | 09/19/1988SE |
| K872882 | Cannabinoid Enzyme Immunoassay KitLDJ · Traditional | 11/03/1987SE |
| K871305 | Cocaine Metabolite Enzyme Immunoassay KitDIO · Traditional | 06/05/1987SE |
| K864993 | Quali. Enzyme Immuno. of Barbiturates in UrineDIS · Traditional | 03/31/1987SE |
| K863877 | Benzodiazepine Enzyme Immunoassay KitJXM · Traditional | 03/12/1987SE |
| K842307 | General Diag. Cefonicid 30MCG AntimicJTN · Traditional | 07/20/1984SE |
| K841465 | General Diagnostics Platelet AntibodyLLG · Traditional | 07/02/1984SE |
| K833709 | Ceftizoxime 30 MCG Antimicrobial DiskJTN · Traditional | 12/30/1983SE |
| K832653 | Cefuroxime 30MCG. Suscep DiskJTN · Traditional | 10/14/1983SE |
| K831179 | Cefazolin 30MCG. Antimicrobial SuscepJTN · Traditional | 05/09/1983SE |
| K830731 | Netilmicin 30 MCG Antimicrobial DiskJTN · Traditional | 04/08/1983SE |
| K823453 | Von Willebrand Factor AssayGGP · Traditional | 01/21/1983SE |
| K823794 | Control TM 8GLQ · Traditional | 01/14/1983SE |
| K822809 | Azlocillin 75 MCG Susceptibility DiscJTN · Traditional | 11/22/1982SE |
| K821229 | Cefoperazone 75MCG. Antimicrobial DiskJTN · Traditional | 06/22/1982SE |
| K820468 | Profile General Set Assayed Serum ContrDIF · Traditional | 03/25/1982SE |
| K820019 | Piperacillin 100MCG. AntimicrobialJTN · Traditional | 01/29/1982SE |
| K813564 | Coag-A-Mate X2GKP · Traditional | 01/28/1982SE |
| K812994 | Minocycline 30MCG Antimicrobial Sus. DSKJTN · Traditional | 12/17/1981SE |
| K812993 | Moxalactom 30MCG Antimicrobial Sus. DiskJTN · Traditional | 11/10/1981SE |
| K812916 | Mezlocillin 75MCG Antimicrob. Suscept. DJTN · Traditional | 11/06/1981SE |
| K812783 | Trimethoprim 5MCG. Antimicrobial DiskJTN · Traditional | 10/23/1981SE |
| K803039 | Profile Anti-Convul. Set Assayed S. Ctl.DIF · Traditional | 12/22/1980SE |
| K803036 | Profile Cardiac Set Assayed Serum Contr.DIF · Traditional | 12/22/1980SE |
| K802117 | Fibri QuikGJA · Traditional | 09/26/1980SE |
| K800925 | Verify S Prod. #34141GGW · Traditional | 07/21/1980SE |
| K800926 | Thromboquik Thrombin Reagent Prod. #3551GJA · Traditional | 05/08/1980SE |
| K792480 | Chem-Strate TriglycerideCDT · Traditional | 12/27/1979SE |
| K792479 | Chem-Strate AmylaseCIJ · Traditional | 12/27/1979SE |
| K792478 | Chem-Strate CholesterolCHH · Traditional | 12/27/1979SE |
| K792477 | Chem-Strate Ck-NacCGS · Traditional | 12/27/1979SE |
| K790372 | H-D-ElLBR · Traditional | 05/03/1979SE |
| K790323 | Coag-A-Mate 2001JPA · Traditional | 03/21/1979SE |
| K781781 | HeparsorbGJA · Traditional | 01/10/1979SE |
| K781814 | Sulfate, Fibriquik ProtamineJBN · Traditional | 11/08/1978SE |
| K780285 | Soluble CollagenJOZ · Traditional | 03/30/1978SE |
| K772106 | PH Calibration BuffersJIT · Traditional | 12/06/1977SE |
| K761250 | SimplateJCA · Traditional | 03/01/1977SE |
| K760790 | Micro-IdJSS · Traditional | 10/29/1976SE |