Medical Device Manufacturer · US , Augusta , GA

Medical Diagnostic Technologies, Inc.

57 submissions · 57 cleared · Since 1985
57
Total
57
Cleared
0
Denied

Medical Diagnostic Technologies, Inc. — FDA 510(k) Submissions

Medical Diagnostic Technologies, Inc. has submitted 57 FDA 510(k) premarket notifications since 1985, of which 57 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Plasma, Coagulation Factor Deficient, Test, Qualitative And Quantitative Factor Deficiency, Reagent, Borrelia Serological Reagent, Control, Plasma, Abnormal, Drug Mixture Control Materials . Use the specialty filter in the sidebar to narrow results.

57 devices
1–25 of 57
CTC WORKSTATION, MODEL 2200
K062229 · LLZ System, Image Processing,... · Radiology
Sep 2006 40d
SPECTROLYSE HEPARIN (ANTI-IIA)
K972209 · KFF Assay, Heparin · Hematology
Aug 1997 62d
CHROMOLIZE PAI-1 KIT
K963106 · GGP Test, Qualitative And... · Hematology
Nov 1996 98d
SPECTROLYSE ANTITHROMBIN III (ANTI-XA)
K960871 · JBQ Antithrombin Iii... · Hematology
Aug 1996 163d
CHROMOLIZE TPA ASSAY KIT
K962489 · GGP Test, Qualitative And... · Hematology
Jul 1996 35d
TINTELIZE PAI-1 KIT
K960438 · GGP Test, Qualitative And... · Hematology
Jun 1996 126d
U-DOA CONTROLS
K961724 · DIF Drug Mixture Control... · Toxicology
Jun 1996 31d
LA POSITIVE CONTROL PLASMA
K961370 · GGC Control, Plasma, Abnormal · Hematology
May 1996 45d
VENOM TIEM REAGENT
K955115 · JCO Bothrops Atrox Reagent · Hematology
Apr 1996 146d
BIOCLOT PROTEIN S
K955738 · GGP Test, Qualitative And... · Hematology
Feb 1996 76d
ALKALINE PHOSPHATASE REAGENT SYSTEM
K952746 · CJE Nitrophenylphosphate,... · Chemistry
Nov 1995 164d
ASPARTATE AMINOTRANSFERASE REAGENT SYSTEM
K952743 · CIT Nadh Oxidation/nad... · Chemistry
Sep 1995 105d
TRIGLYCERIDES (GLYCEROL BLANKING) REAGENT SYSTEM
K952741 · CDT Lipase... · Chemistry
Aug 1995 62d
BLOOD UREA NITROGEN REAGENT SYSTEM
K952742 · CDQ Urease And Glutamic... · Chemistry
Aug 1995 56d
CREATINE KINASE REAGENT SYSTEM
K952745 · CGS Nad Reduction/nadh... · Chemistry
Aug 1995 56d
ALANINE AMINOTRANSFERASE REAGENT SYSTEM
K952744 · CKA Nadh Oxidation/nad... · Chemistry
Aug 1995 52d
LACTATE DEHYDROGENASE REAGENT SYSTEM
K952747 · CFJ Nad Reduction/nadh... · Chemistry
Aug 1995 52d
REMEL RIM STREPTOCOCCUS GROUPING LATEX AGGLUTINATION TEST
K942093 · GTZ Antisera, All Groups,... · Microbiology
Nov 1994 210d
DOA-PLUS, DRUGS OF ABUSE CONTROLS
K942257 · DIF Drug Mixture Control... · Toxicology
Sep 1994 128d
LIPASE REAGENT SYSTEM
K940457 · CET Olive Oil Emulsion... · Chemistry
Jun 1994 121d
DRUGS OF ABUSE CONTROLS
K935285 · DIF Drug Mixture Control... · Toxicology
Mar 1994 139d
APTT-ES REAGENT
K934351 · GFO Activated Partial... · Hematology
Dec 1993 90d
MYCOPLASMA PNEUMONIAE IGG/IGM ANTIBODY TEST SYSTEM
K921556 · LJZ Enzyme Linked... · Microbiology
Jun 1992 89d
RISTOCETIN COFACTOR ASSAY/VON WILLEBRAND FACT ASSA
K920981 · GGP Test, Qualitative And... · Hematology
Apr 1992 46d
BORRELIA BURGDORFERI POLYVAL IGG/IGM ANTIBODY TEST
K911145 · LSR Reagent, Borrelia... · Microbiology
May 1991 70d
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