Medical Device Manufacturer · US , Walker , MI

Diagnostic Chemicals, Ltd. (Usa) - FDA 510(k) Cleared Devices

77 submissions · 76 cleared · Since 1984
77
Total
76
Cleared
0
Denied
77 devices
26-50 of 77
Cleared Feb 02, 1988
LACTATE DEHYDROGENASE CAT. # 320-68, 320-69
K875206 · CFJ
Chemistry · 46d
Cleared Feb 02, 1988
ALKALINE PHOSPHATASE CAT. # 306-22, 306-23
K875210 · CJE
Chemistry · 46d
Cleared Feb 01, 1988
ACID PHOSPHATASE (KINETIC) CAT. # 320-06
K875209 · CKB
Chemistry · 45d
Cleared Jan 21, 1988
SHOT-GUN ISOLAT PROCED/MEASUREMENT CK-MB IN SERUM
K874284 · JHT
Chemistry · 99d
Cleared Jan 05, 1988
DC-TROL LEVEL 1 OR 2
K874772 · JJY
Chemistry · 47d
Cleared Feb 20, 1987
SALICYLATE ASSAY KIT, CATALOGUE NUMBER 501-71
K870336 · DKJ
Chemistry · 23d
Cleared Aug 19, 1986
MODEL 303-47/303-48 ALANINE AMINOTRANSFERASE KIT
K862833 · CKA
Chemistry · 25d
Cleared Aug 19, 1986
MODEL 115-16 PHOSPHORUS (UV) ASSAY KIT
K862834 · CEO
Chemistry · 25d
Cleared Aug 12, 1986
MODEL 303-42/303-43 ASPARTATE AMINOTRANSFERASE KIT
K862832 · CIT
Chemistry · 18d
Cleared Apr 21, 1986
BILIRUBIN ASSAY KIT (DIRECT), CATA. NUMBER 202-02
K861094 · CIG
Chemistry · 28d
Cleared Apr 21, 1986
BILIRUBIN ASSAY KIT (TOTAL), CATA. NUMBER 202-04
K861095 · CIG
Chemistry · 28d
Cleared Mar 17, 1986
GLUCOSE HK-60 ASSAY KIT CAT. #201-39
K860625 · CFR
Chemistry · 26d
Cleared Aug 02, 1985
DC LIQUITROL LEVEL 1 & 2
K852753 · JJY
Chemistry · 35d
Cleared Aug 02, 1985
UREASE & GLUTAMATE DEHYDROGENASE, UREA NITROGEN
K853102 · CDQ
Chemistry · 10d
Cleared Jul 12, 1985
CHLORIDE ASSAY KIT
K852058 · CHJ
Chemistry · 64d
Cleared Jul 12, 1985
DC-LIP, CATALOGUE NUMBER SE-020
K852594 · JJY
Chemistry · 23d
Cleared Jul 12, 1985
DC-3 FLUIDS PACK, DC-5 FLUIDS PACK
K852595 · JGS
Chemistry · 23d
Cleared Jul 12, 1985
X-AMYLASE ASSAY KIT
K852636 · CIJ
Chemistry · 22d
Cleared Mar 19, 1985
GLUTAMYLTRANSFERASE ASSAY KIT
K850788 · JPZ
Chemistry · 21d
Cleared Oct 22, 1984
SALICYLATE ASSAY KIT
K842158 · DKJ
Chemistry · 145d
Cleared Oct 11, 1984
TRIGLYCERIDE ASSAY KIT GPO-CP
K843536 · CDT
Chemistry · 34d
Cleared Oct 05, 1984
STANDARDS & ACCESSORIES FOR NOVA INSTRU
K842873 · JGS
Chemistry · 74d
Cleared Sep 28, 1984
CREATININE ASSAY KIT
K843377 · CGX
Chemistry · 31d
Cleared Sep 28, 1984
VMA ASSAY KIT
K843379 · CDF
Chemistry · 31d
Cleared Sep 20, 1984
ACID PHOSPHATASE ASSAY KIT
K843380 · CKE
Chemistry · 23d

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