Company ยท US
Diagnostic Systems
FDA 510(k) clearances and medical device recalls filed under this name, 1983 to 1991. Name variants (Inc, Corp, punctuation) are merged.
14510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JIT | Calibrator, Secondary | 2 |
| CEW | Radioimmunoassay, Parathyroid Hormone | 1 |
| CGA | Glucose Oxidase, Glucose | 1 |
| CGI | Radioimmunoassay, Estriol | 1 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 1 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 1 |
| DKB | Calibrators, Drug Mixture | 1 |
| DNN | Calibrators, Ethyl Alcohol | 1 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 |
| JQY | Ph Meter | 1 |
| KHP | Acid, Lactic, Enzymatic Method | 1 |
| KLR | Enzyme Immunoassay, Lidocaine | 1 |
| LBR | Ldl & Vldl Precipitation, Hdl | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 4, 1991 | K905146 | OLYMPUS URINE PH Diagnostic Systems | JQY |
| Aug 31, 1989 | K893691 | EMDS CREATINE KINASE ITEM NIMBER 65411 Diagnostic Systems | CGS |
| Aug 21, 1989 | K893692 | EMDS ASPARTATE AMINOTRANSFERASE ITEM NUMBER 65405 Diagnostic Systems | CIT |
| Jul 25, 1989 | K893966 | HDL PRECIPITATING REAGENT Diagnostic Systems | LBR |
| Dec 29, 1988 | K884993 | VISUAL BLOOD GLUCOSE TEST SYSTEM Diagnostic Systems | CGA |
| Jun 20, 1988 | K881116 | EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641 Diagnostic Systems | KLR |
| Mar 15, 1988 | K880787 | EASY-TEST LACTIC ACID (LA) Diagnostic Systems | KHP |
| Jul 11, 1986 | K862403 | EMDS ANTIEPILEPTIC DRUG CALIBRATORS ITEM #67630/95 Diagnostic Systems | DKB |
| Dec 19, 1985 | K854784 | ABSORBANCE (ABS) TEST PAK Diagnostic Systems | JIT |
| Sep 25, 1985 | K853699 | EASY ANALYZER & EASY-TEST REAGENT Diagnostic Systems | JJE |
| Sep 16, 1985 | K853533 | ABSORBANCE TEST SOLUTION Diagnostic Systems | JIT |
| Sep 16, 1985 | K853532 | ALCOHOL CALIBRATORS Diagnostic Systems | DNN |
| Apr 12, 1983 | K830816 | DSL 1900 Diagnostic Systems | CGI |
| Apr 6, 1983 | K830700 | MMH PTH RIA KIT Diagnostic Systems | CEW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||