Medical Device Manufacturer · US , Augusta , GA

Medical Diagnostic Technologies, Inc. - FDA 510(k) Cleared Devices

57 submissions · 57 cleared · Since 1985

Recent clearances: CTC WORKSTATION, MODEL 2200, SPECTROLYSE HEPARIN (ANTI-IIA), CHROMOLIZE PAI-1 KIT

57
Total
57
Cleared
0
Denied

FDA 510(k) Regulatory Record - Medical Diagnostic Technologies, Inc. Chemistry ✕

8 devices
1-8 of 8
Cleared Nov 27, 1995
ALKALINE PHOSPHATASE REAGENT SYSTEM
K952746 · CJE
Chemistry · 164d
Cleared Sep 29, 1995
ASPARTATE AMINOTRANSFERASE REAGENT SYSTEM
K952743 · CIT
Chemistry · 105d
Cleared Aug 17, 1995
TRIGLYCERIDES (GLYCEROL BLANKING) REAGENT SYSTEM
K952741 · CDT
Chemistry · 62d
Cleared Aug 11, 1995
BLOOD UREA NITROGEN REAGENT SYSTEM
K952742 · CDQ
Chemistry · 56d
Cleared Aug 11, 1995
CREATINE KINASE REAGENT SYSTEM
K952745 · CGS
Chemistry · 56d
Cleared Aug 07, 1995
ALANINE AMINOTRANSFERASE REAGENT SYSTEM
K952744 · CKA
Chemistry · 52d
Cleared Aug 07, 1995
LACTATE DEHYDROGENASE REAGENT SYSTEM
K952747 · CFJ
Chemistry · 52d
Cleared Jun 02, 1994
LIPASE REAGENT SYSTEM
K940457 · CET
Chemistry · 121d
Filters
Filter by Specialty
All57 Hematology 32 Microbiology 13 Chemistry 8 Toxicology 3 Radiology 1