Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Medical Diagnostic Technologies, Inc. · Predicate Candidate Screening
57 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
52 daysmedian FDA review time
146 days90th percentile
57clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K062229 | CTC WORKSTATION, MODEL 2200 | Medical Diagnostic Technologies, Inc. | 2006-09-11 | 40 | 0 |
| K972209 | SPECTROLYSE HEPARIN (ANTI-IIA) | Medical Diagnostic Technologies, Inc. | 1997-08-12 | 62 | 0 |
| K963106 | CHROMOLIZE PAI-1 KIT | Medical Diagnostic Technologies, Inc. | 1996-11-18 | 98 | 0 |
| K960871 | SPECTROLYSE ANTITHROMBIN III (ANTI-XA) | Medical Diagnostic Technologies, Inc. | 1996-08-14 | 163 | 0 |
| K962489 | CHROMOLIZE TPA ASSAY KIT | Medical Diagnostic Technologies, Inc. | 1996-07-31 | 35 | 0 |
| K960438 | TINTELIZE PAI-1 KIT | Medical Diagnostic Technologies, Inc. | 1996-06-05 | 126 | 0 |
| K961724 | U-DOA CONTROLS | Medical Diagnostic Technologies, Inc. | 1996-06-03 | 31 | 0 |
| K961370 | LA POSITIVE CONTROL PLASMA | Medical Diagnostic Technologies, Inc. | 1996-05-24 | 45 | 0 |
| K955115 | VENOM TIEM REAGENT | Medical Diagnostic Technologies, Inc. | 1996-04-03 | 146 | 0 |
| K955738 | BIOCLOT PROTEIN S | Medical Diagnostic Technologies, Inc. | 1996-02-29 | 76 | 0 |
| K952746 | ALKALINE PHOSPHATASE REAGENT SYSTEM | Medical Diagnostic Technologies, Inc. | 1995-11-27 | 164 | 0 |
| K952743 | ASPARTATE AMINOTRANSFERASE REAGENT SYSTEM | Medical Diagnostic Technologies, Inc. | 1995-09-29 | 105 | 0 |
| K952741 | TRIGLYCERIDES (GLYCEROL BLANKING) REAGENT SYSTEM | Medical Diagnostic Technologies, Inc. | 1995-08-17 | 62 | 0 |
| K952742 | BLOOD UREA NITROGEN REAGENT SYSTEM | Medical Diagnostic Technologies, Inc. | 1995-08-11 | 56 | 0 |
| K952745 | CREATINE KINASE REAGENT SYSTEM | Medical Diagnostic Technologies, Inc. | 1995-08-11 | 56 | 0 |
| K952744 | ALANINE AMINOTRANSFERASE REAGENT SYSTEM | Medical Diagnostic Technologies, Inc. | 1995-08-07 | 52 | 0 |
| K952747 | LACTATE DEHYDROGENASE REAGENT SYSTEM | Medical Diagnostic Technologies, Inc. | 1995-08-07 | 52 | 0 |
| K942093 | REMEL RIM STREPTOCOCCUS GROUPING LATEX AGGLUTINATION TEST | Medical Diagnostic Technologies, Inc. | 1994-11-28 | 210 | 0 |
| K942257 | DOA-PLUS, DRUGS OF ABUSE CONTROLS | Medical Diagnostic Technologies, Inc. | 1994-09-14 | 128 | 0 |
| K940457 | LIPASE REAGENT SYSTEM | Medical Diagnostic Technologies, Inc. | 1994-06-02 | 121 | 0 |
| K935285 | DRUGS OF ABUSE CONTROLS | Medical Diagnostic Technologies, Inc. | 1994-03-22 | 139 | 0 |
| K934351 | APTT-ES REAGENT | Medical Diagnostic Technologies, Inc. | 1993-12-06 | 90 | 0 |
| K921556 | MYCOPLASMA PNEUMONIAE IGG/IGM ANTIBODY TEST SYSTEM | Medical Diagnostic Technologies, Inc. | 1992-06-29 | 89 | 0 |
| K920981 | RISTOCETIN COFACTOR ASSAY/VON WILLEBRAND FACT ASSA | Medical Diagnostic Technologies, Inc. | 1992-04-17 | 46 | 0 |
| K911145 | BORRELIA BURGDORFERI POLYVAL IGG/IGM ANTIBODY TEST | Medical Diagnostic Technologies, Inc. | 1991-05-10 | 70 | 0 |
| K910286 | PLATELET AGGREGATION REAGENTS | Medical Diagnostic Technologies, Inc. | 1991-03-19 | 56 | 0 |
| K904501 | MYCOPLASMA PNEUMONIAE ANTIBODY TEST SYSTEM | Medical Diagnostic Technologies, Inc. | 1991-02-26 | 147 | 0 |
| K905203 | COAGULATION REFERENCE PLASMA, NORMAL | Medical Diagnostic Technologies, Inc. | 1990-12-28 | 38 | 0 |
| K900782 | HEPARIN CONTROL PLASMA, FOR USE IN APTT | Medical Diagnostic Technologies, Inc. | 1990-03-27 | 35 | 0 |
| K900792 | RISTOCETIN | Medical Diagnostic Technologies, Inc. | 1990-03-27 | 35 | 0 |
| K900049 | APTT-EA REAGENT, AN ELLAGIC ACID ACTIVATED REAGENT | Medical Diagnostic Technologies, Inc. | 1990-01-25 | 22 | 0 |
| K900133 | FACTOR II DEFICIENT PLASMA | Medical Diagnostic Technologies, Inc. | 1990-01-25 | 15 | 0 |
| K896625 | THROMBOPLASTIN, FOR USE IN PROTHROMBIN TIME DETER. | Medical Diagnostic Technologies, Inc. | 1989-12-11 | 20 | 0 |
| K896052 | FIBRINOGEN ASSAY KIT | Medical Diagnostic Technologies, Inc. | 1989-11-09 | 22 | 0 |
| K896033 | FDP COLLECTION TUBES | Medical Diagnostic Technologies, Inc. | 1989-10-27 | 11 | 0 |
| K895255 | APTT-P REAGENT, A PARTICLE ACTIVATED REAGENT | Medical Diagnostic Technologies, Inc. | 1989-10-06 | 46 | 0 |
| K895260 | ABNORMAL COAGULATION CONTROL PLASMA-1 (ACCP-1) | Medical Diagnostic Technologies, Inc. | 1989-10-06 | 45 | 0 |
| K895261 | ABNORMAL COAGULATION CONTROL PLASMA-2 (ACCP-2) | Medical Diagnostic Technologies, Inc. | 1989-10-06 | 45 | 0 |
| K895262 | NORMAL COAGULATION CONTROL PLASMA (NCCP) | Medical Diagnostic Technologies, Inc. | 1989-10-06 | 45 | 0 |
| K895503 | ABNORMAL REFERENCE PLASMA-VIII | Medical Diagnostic Technologies, Inc. | 1989-10-06 | 24 | 0 |
| K895504 | ABNORMAL REFERENCE PLASMA-IX | Medical Diagnostic Technologies, Inc. | 1989-10-06 | 24 | 0 |
| K893523 | FACTOR X DEFICIENT PLASMA | Medical Diagnostic Technologies, Inc. | 1989-06-23 | 46 | 0 |
| K893524 | FACTOR IX DEFICIENT PLASMA | Medical Diagnostic Technologies, Inc. | 1989-06-23 | 46 | 0 |
| K893525 | FACTOR VIII DEFICIENT PLASMA | Medical Diagnostic Technologies, Inc. | 1989-06-23 | 46 | 0 |
| K893533 | FACTOR V DEFICIENT PLASMA | Medical Diagnostic Technologies, Inc. | 1989-06-23 | 46 | 0 |
| K893534 | FACTOR XII DEFICIENT PLASMA | Medical Diagnostic Technologies, Inc. | 1989-06-23 | 46 | 0 |
| K893535 | FACTOR VII DEFICIENT PLASMA | Medical Diagnostic Technologies, Inc. | 1989-06-23 | 46 | 0 |
| K893536 | FACTOR XI DEFICIENT PLASMA | Medical Diagnostic Technologies, Inc. | 1989-06-23 | 46 | 0 |
| K885290 | BORRELIA BURGDORFERI POLYVALENT IGG/IGM ANTIBODY | Medical Diagnostic Technologies, Inc. | 1989-04-10 | 104 | 0 |
| K885293 | BORRELIA BURGDORFERI IGG ANTIBODY TEST SYSTEM | Medical Diagnostic Technologies, Inc. | 1989-04-10 | 104 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda