Medical Diagnostic Technologies, Inc.
Las Vegas, NV, US
Medical Diagnostic Technologies, Inc. appears in FDA device records in Las Vegas, NV. FDA records list 57 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 57
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 57FDA records hold 57 510(k) clearances for Medical Diagnostic Technologies, Inc. between 1985 and 2006. The busiest year on record is 1989, with 19. The most recent is 2006, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 1 |
| 1986 | 1 |
| 1987 | 3 |
| 1988 | 1 |
| 1989 | 19 |
| 1990 | 5 |
| 1991 | 3 |
| 1992 | 2 |
| 1993 | 1 |
| 1994 | 4 |
| 1995 | 7 |
| 1996 | 8 |
| 1997 | 1 |
| 2006 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K062229 | CTC WORKSTATION, MODEL 2200 | LLZ | Substantially Equivalent | |
| K972209 | SPECTROLYSE HEPARIN (ANTI-IIA) | KFF | Substantially Equivalent | |
| K963106 | CHROMOLIZE PAI-1 KIT | GGP | Substantially Equivalent | |
| K960871 | SPECTROLYSE ANTITHROMBIN III (ANTI-XA) | JBQ | Substantially Equivalent | |
| K962489 | CHROMOLIZE TPA ASSAY KIT | GGP | Substantially Equivalent | |
| K960438 | TINTELIZE PAI-1 KIT | GGP | Substantially Equivalent | |
| K961724 | U-DOA CONTROLS | DIF | Substantially Equivalent | |
| K961370 | LA POSITIVE CONTROL PLASMA | GGC | Substantially Equivalent | |
| K955115 | VENOM TIEM REAGENT | JCO | Substantially Equivalent | |
| K955738 | BIOCLOT PROTEIN S | GGP | Substantially Equivalent | |
| K952746 | ALKALINE PHOSPHATASE REAGENT SYSTEM | CJE | Substantially Equivalent | |
| K952743 | ASPARTATE AMINOTRANSFERASE REAGENT SYSTEM | CIT | Substantially Equivalent | |
| K952741 | TRIGLYCERIDES (GLYCEROL BLANKING) REAGENT SYSTEM | CDT | Substantially Equivalent | |
| K952745 | CREATINE KINASE REAGENT SYSTEM | CGS | Substantially Equivalent | |
| K952742 | BLOOD UREA NITROGEN REAGENT SYSTEM | CDQ | Substantially Equivalent | |
| K952747 | LACTATE DEHYDROGENASE REAGENT SYSTEM | CFJ | Substantially Equivalent | |
| K952744 | ALANINE AMINOTRANSFERASE REAGENT SYSTEM | CKA | Substantially Equivalent | |
| K942093 | REMEL RIM STREPTOCOCCUS GROUPING LATEX AGGLUTINATION TEST | GTZ | Substantially Equivalent | |
| K942257 | DOA-PLUS, DRUGS OF ABUSE CONTROLS | DIF | Substantially Equivalent | |
| K940457 | LIPASE REAGENT SYSTEM | CET | Substantially Equivalent | |
| K935285 | DRUGS OF ABUSE CONTROLS | DIF | Substantially Equivalent | |
| K934351 | APTT-ES REAGENT | GFO | Substantially Equivalent | |
| K921556 | MYCOPLASMA PNEUMONIAE IGG/IGM ANTIBODY TEST SYSTEM | LJZ | Substantially Equivalent | |
| K920981 | RISTOCETIN COFACTOR ASSAY/VON WILLEBRAND FACT ASSA | GGP | Substantially Equivalent | |
| K911145 | BORRELIA BURGDORFERI POLYVAL IGG/IGM ANTIBODY TEST | LSR | Substantially Equivalent | |
| K910286 | PLATELET AGGREGATION REAGENTS | GHR | Substantially Equivalent | |
| K904501 | MYCOPLASMA PNEUMONIAE ANTIBODY TEST SYSTEM | LJZ | Substantially Equivalent | |
| K905203 | COAGULATION REFERENCE PLASMA, NORMAL | GIZ | Substantially Equivalent | |
| K900792 | RISTOCETIN | GHR | Substantially Equivalent | |
| K900782 | HEPARIN CONTROL PLASMA, FOR USE IN APTT | GGC | Substantially Equivalent | |
| K900133 | FACTOR II DEFICIENT PLASMA | GJT | Substantially Equivalent | |
| K900049 | APTT-EA REAGENT, AN ELLAGIC ACID ACTIVATED REAGENT | GFO | Substantially Equivalent | |
| K896625 | THROMBOPLASTIN, FOR USE IN PROTHROMBIN TIME DETER. | GJS | Substantially Equivalent | |
| K896052 | FIBRINOGEN ASSAY KIT | KQJ | Substantially Equivalent | |
| K896033 | FDP COLLECTION TUBES | JCO | Substantially Equivalent | |
| K895504 | ABNORMAL REFERENCE PLASMA-IX | GJT | Substantially Equivalent | |
| K895503 | ABNORMAL REFERENCE PLASMA-VIII | GJT | Substantially Equivalent | |
| K895262 | NORMAL COAGULATION CONTROL PLASMA (NCCP) | GIZ | Substantially Equivalent | |
| K895261 | ABNORMAL COAGULATION CONTROL PLASMA-2 (ACCP-2) | GGC | Substantially Equivalent | |
| K895260 | ABNORMAL COAGULATION CONTROL PLASMA-1 (ACCP-1) | GGC | Substantially Equivalent | |
| K895255 | APTT-P REAGENT, A PARTICLE ACTIVATED REAGENT | GFO | Substantially Equivalent | |
| K893536 | FACTOR XI DEFICIENT PLASMA | GJT | Substantially Equivalent | |
| K893535 | FACTOR VII DEFICIENT PLASMA | GJT | Substantially Equivalent | |
| K893534 | FACTOR XII DEFICIENT PLASMA | GJT | Substantially Equivalent | |
| K893533 | FACTOR V DEFICIENT PLASMA | GJT | Substantially Equivalent | |
| K893525 | FACTOR VIII DEFICIENT PLASMA | GJT | Substantially Equivalent | |
| K893524 | FACTOR IX DEFICIENT PLASMA | GJT | Substantially Equivalent | |
| K893523 | FACTOR X DEFICIENT PLASMA | GJT | Substantially Equivalent | |
| K885294 | BORRELIA BURGDORFERI IGM ANTIBODY TEST SYSTEM | LSR | Substantially Equivalent | |
| K885293 | BORRELIA BURGDORFERI IGG ANTIBODY TEST SYSTEM | LSR | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- GFOActivated Partial Thromboplastin
- GQHAntigen, Cf (Including Cf Control), Cytomegalovirus
- GTZAntisera, All Groups, Streptococcus Spp.
- GSAAntisera, All Mycoplasma Spp.
- JBQAntithrombin Iii Quantitation
- KFFAssay, Heparin
- JCOBothrops Atrox Reagent
- GGCControl, Plasma, Abnormal
- DIFDrug Mixture Control Materials
- LJZEnzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.
- CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
- CFJNad Reduction/Nadh Oxidation, Lactate Dehydrogenase
- CKANadh Oxidation/Nad Reduction, Alt/Sgpt
- CITNadh Oxidation/Nad Reduction, Ast/Sgot
- CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- CETOlive Oil Emulsion (Turbidimetric), Lipase
- GJTPlasma, Coagulation Factor Deficient
- GIZPlasma, Control, Normal
- LSRReagent, Borrelia Serological Reagent
- GHRReagent, Platelet Aggregation
- LHLReagents, Antibody, Legionella, Direct & Indirect Fluorescent
- LKTRespiratory Syncytial Virus, Antigen, Antibody, Ifa
- KQJSystem, Fibrinogen Determination
- LLZSystem, Image Processing, Radiological
- GGPTest, Qualitative And Quantitative Factor Deficiency
- GJSTest, Time, Prothrombin
- CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Medical Diagnostic Technologies, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Medical Diagnostic Technologies, Inc.. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.
Data as of , FDA export datePage updated Source: openFDA, public domain