Company ยท US
Medical Diagnostic Technologies, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1985 to 2006. Name variants (Inc, Corp, punctuation) are merged.
57510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GJT | Plasma, Coagulation Factor Deficient | 10 |
| GGP | Test, Qualitative And Quantitative Factor Deficiency | 5 |
| GGC | Control, Plasma, Abnormal | 4 |
| LSR | Reagent, Borrelia Serological Reagent | 4 |
| DIF | Drug Mixture Control Materials | 3 |
| GFO | Activated Partial Thromboplastin | 3 |
| GHR | Reagent, Platelet Aggregation | 2 |
| GIZ | Plasma, Control, Normal | 2 |
| GSA | Antisera, All Mycoplasma Spp. | 2 |
| JCO | Bothrops Atrox Reagent | 2 |
| LHL | Reagents, Antibody, Legionella, Direct & Indirect Fluorescent | 2 |
| LJZ | Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. | 2 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 1 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 |
| CET | Olive Oil Emulsion (Turbidimetric), Lipase | 1 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 1 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 1 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 1 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 1 |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 11, 2006 | K062229 | CTC WORKSTATION, MODEL 2200 Medical Diagnostic Technologies, Inc. | LLZ |
| Aug 12, 1997 | K972209 | SPECTROLYSE HEPARIN (ANTI-IIA) Medical Diagnostic Technologies, Inc. | KFF |
| Nov 18, 1996 | K963106 | CHROMOLIZE PAI-1 KIT Medical Diagnostic Technologies, Inc. | GGP |
| Aug 14, 1996 | K960871 | SPECTROLYSE ANTITHROMBIN III (ANTI-XA) Medical Diagnostic Technologies, Inc. | JBQ |
| Jul 31, 1996 | K962489 | CHROMOLIZE TPA ASSAY KIT Medical Diagnostic Technologies, Inc. | GGP |
| Jun 5, 1996 | K960438 | TINTELIZE PAI-1 KIT Medical Diagnostic Technologies, Inc. | GGP |
| Jun 3, 1996 | K961724 | U-DOA CONTROLS Medical Diagnostic Technologies, Inc. | DIF |
| May 24, 1996 | K961370 | LA POSITIVE CONTROL PLASMA Medical Diagnostic Technologies, Inc. | GGC |
| Apr 3, 1996 | K955115 | VENOM TIEM REAGENT Medical Diagnostic Technologies, Inc. | JCO |
| Feb 29, 1996 | K955738 | BIOCLOT PROTEIN S Medical Diagnostic Technologies, Inc. | GGP |
| Nov 27, 1995 | K952746 | ALKALINE PHOSPHATASE REAGENT SYSTEM Medical Diagnostic Technologies, Inc. | CJE |
| Sep 29, 1995 | K952743 | ASPARTATE AMINOTRANSFERASE REAGENT SYSTEM Medical Diagnostic Technologies, Inc. | CIT |
| Aug 17, 1995 | K952741 | TRIGLYCERIDES (GLYCEROL BLANKING) REAGENT SYSTEM Medical Diagnostic Technologies, Inc. | CDT |
| Aug 11, 1995 | K952745 | CREATINE KINASE REAGENT SYSTEM Medical Diagnostic Technologies, Inc. | CGS |
| Aug 11, 1995 | K952742 | BLOOD UREA NITROGEN REAGENT SYSTEM Medical Diagnostic Technologies, Inc. | CDQ |
| Aug 7, 1995 | K952747 | LACTATE DEHYDROGENASE REAGENT SYSTEM Medical Diagnostic Technologies, Inc. | CFJ |
| Aug 7, 1995 | K952744 | ALANINE AMINOTRANSFERASE REAGENT SYSTEM Medical Diagnostic Technologies, Inc. | CKA |
| Nov 28, 1994 | K942093 | REMEL RIM STREPTOCOCCUS GROUPING LATEX AGGLUTINATION TEST Medical Diagnostic Technologies, Inc. | GTZ |
| Sep 14, 1994 | K942257 | DOA-PLUS, DRUGS OF ABUSE CONTROLS Medical Diagnostic Technologies, Inc. | DIF |
| Jun 2, 1994 | K940457 | LIPASE REAGENT SYSTEM Medical Diagnostic Technologies, Inc. | CET |
| Mar 22, 1994 | K935285 | DRUGS OF ABUSE CONTROLS Medical Diagnostic Technologies, Inc. | DIF |
| Dec 6, 1993 | K934351 | APTT-ES REAGENT Medical Diagnostic Technologies, Inc. | GFO |
| Jun 29, 1992 | K921556 | MYCOPLASMA PNEUMONIAE IGG/IGM ANTIBODY TEST SYSTEM Medical Diagnostic Technologies, Inc. | LJZ |
| Apr 17, 1992 | K920981 | RISTOCETIN COFACTOR ASSAY/VON WILLEBRAND FACT ASSA Medical Diagnostic Technologies, Inc. | GGP |
| May 10, 1991 | K911145 | BORRELIA BURGDORFERI POLYVAL IGG/IGM ANTIBODY TEST Medical Diagnostic Technologies, Inc. | LSR |
| Mar 19, 1991 | K910286 | PLATELET AGGREGATION REAGENTS Medical Diagnostic Technologies, Inc. | GHR |
| Feb 26, 1991 | K904501 | MYCOPLASMA PNEUMONIAE ANTIBODY TEST SYSTEM Medical Diagnostic Technologies, Inc. | LJZ |
| Dec 28, 1990 | K905203 | COAGULATION REFERENCE PLASMA, NORMAL Medical Diagnostic Technologies, Inc. | GIZ |
| Mar 27, 1990 | K900792 | RISTOCETIN Medical Diagnostic Technologies, Inc. | GHR |
| Mar 27, 1990 | K900782 | HEPARIN CONTROL PLASMA, FOR USE IN APTT Medical Diagnostic Technologies, Inc. | GGC |
| Jan 25, 1990 | K900133 | FACTOR II DEFICIENT PLASMA Medical Diagnostic Technologies, Inc. | GJT |
| Jan 25, 1990 | K900049 | APTT-EA REAGENT, AN ELLAGIC ACID ACTIVATED REAGENT Medical Diagnostic Technologies, Inc. | GFO |
| Dec 11, 1989 | K896625 | THROMBOPLASTIN, FOR USE IN PROTHROMBIN TIME DETER. Medical Diagnostic Technologies, Inc. | GJS |
| Nov 9, 1989 | K896052 | FIBRINOGEN ASSAY KIT Medical Diagnostic Technologies, Inc. | KQJ |
| Oct 27, 1989 | K896033 | FDP COLLECTION TUBES Medical Diagnostic Technologies, Inc. | JCO |
| Oct 6, 1989 | K895504 | ABNORMAL REFERENCE PLASMA-IX Medical Diagnostic Technologies, Inc. | GJT |
| Oct 6, 1989 | K895503 | ABNORMAL REFERENCE PLASMA-VIII Medical Diagnostic Technologies, Inc. | GJT |
| Oct 6, 1989 | K895262 | NORMAL COAGULATION CONTROL PLASMA (NCCP) Medical Diagnostic Technologies, Inc. | GIZ |
| Oct 6, 1989 | K895261 | ABNORMAL COAGULATION CONTROL PLASMA-2 (ACCP-2) Medical Diagnostic Technologies, Inc. | GGC |
| Oct 6, 1989 | K895260 | ABNORMAL COAGULATION CONTROL PLASMA-1 (ACCP-1) Medical Diagnostic Technologies, Inc. | GGC |
| Oct 6, 1989 | K895255 | APTT-P REAGENT, A PARTICLE ACTIVATED REAGENT Medical Diagnostic Technologies, Inc. | GFO |
| Jun 23, 1989 | K893536 | FACTOR XI DEFICIENT PLASMA Medical Diagnostic Technologies, Inc. | GJT |
| Jun 23, 1989 | K893535 | FACTOR VII DEFICIENT PLASMA Medical Diagnostic Technologies, Inc. | GJT |
| Jun 23, 1989 | K893534 | FACTOR XII DEFICIENT PLASMA Medical Diagnostic Technologies, Inc. | GJT |
| Jun 23, 1989 | K893533 | FACTOR V DEFICIENT PLASMA Medical Diagnostic Technologies, Inc. | GJT |
| Jun 23, 1989 | K893525 | FACTOR VIII DEFICIENT PLASMA Medical Diagnostic Technologies, Inc. | GJT |
| Jun 23, 1989 | K893524 | FACTOR IX DEFICIENT PLASMA Medical Diagnostic Technologies, Inc. | GJT |
| Jun 23, 1989 | K893523 | FACTOR X DEFICIENT PLASMA Medical Diagnostic Technologies, Inc. | GJT |
| Apr 10, 1989 | K885294 | BORRELIA BURGDORFERI IGM ANTIBODY TEST SYSTEM Medical Diagnostic Technologies, Inc. | LSR |
| Apr 10, 1989 | K885293 | BORRELIA BURGDORFERI IGG ANTIBODY TEST SYSTEM Medical Diagnostic Technologies, Inc. | LSR |
Newest 50 of 57.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||