Diagnostic Systems
Medical device manufacturer in Gibbstown, NJ.
14510(k) clearances
0PMA approvals
0recalls
Device types
- JIT Calibrator, Secondary 2
- CEW Radioimmunoassay, Parathyroid Hormone 1
- CGI Radioimmunoassay, Estriol 1
- DNN Calibrators, Ethyl Alcohol 1
- JJE Analyzer, Chemistry (Photometric… 1
- DKB Calibrators, Drug Mixture 1
- KHP Acid, Lactic, Enzymatic Method 1
- KLR Enzyme Immunoassay, Lidocaine 1
- CGA Glucose Oxidase, Glucose 1
- LBR Ldl & Vldl Precipitation, Hdl 1
- CIT Nadh Oxidation/Nad Reduction, Ast/Sgot 1
- CGS Nad Reduction/Nadh Oxidation, Cpk Or… 1
- JQY Ph Meter 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K905146 | Olympus Urine PHJQY · Traditional | 02/04/1991SE |
| K893691 | Emds Creatine Kinase Item Nimber 65411CGS · Traditional | 08/31/1989SE |
| K893692 | Emds Aspartate Aminotransferase Item Number 65405CIT · Traditional | 08/21/1989SE |
| K893966 | HDL Precipitating ReagentLBR · Traditional | 07/25/1989SE |
| K884993 | Visual Blood Glucose Test SystemCGA · Traditional | 12/29/1988SE |
| K881116 | Easy-Test Emit(R) Lidocaine Lido Item No. 16641KLR · Traditional | 06/20/1988SE |
| K880787 | Easy-Test Lactic Acid (la)KHP · Traditional | 03/15/1988SE |
| K862403 | Emds Antiepileptic Drug Calibrators Item #67630/95DKB · Traditional | 07/11/1986SE |
| K854784 | Absorbance (Abs) Test PakJIT · Traditional | 12/19/1985SE |
| K853699 | Easy Analyzer & Easy-Test ReagentJJE · Traditional | 09/25/1985SE |
| K853533 | Absorbance Test SolutionJIT · Traditional | 09/16/1985SE |
| K853532 | Alcohol CalibratorsDNN · Traditional | 09/16/1985SE |
| K830816 | DSL 1900CGI · Traditional | 04/12/1983SE |
| K830700 | MMH PTH Ria KitCEW · Traditional | 04/06/1983SE |