Medical Device Manufacturer · US , Walker , MI

The Dow Chemical Co. - FDA 510(k) Cleared Devices

26 submissions · 26 cleared · Since 1976
26
Total
26
Cleared
0
Denied

FDA 510(k) Regulatory Record - The Dow Chemical Co. Chemistry

24 devices
1-24 of 24
Cleared Dec 30, 1982
ENZYMATIC GLUCOSE DETERMINATION
K823474 · CGA
Chemistry · 38d
Cleared Aug 05, 1982
UREA NITROGEN (ENZYMATIC) DETERMINATION
K822154 · CDN
Chemistry · 13d
Cleared Jun 14, 1982
DOWFLOW ALT-UV DETERMINATION
K821536 · CKA
Chemistry · 21d
Cleared May 24, 1982
DOWFLOW ENZYMATIC TRIGLYCERIDES DETERM
K821315 · CDT
Chemistry · 20d
Cleared Apr 01, 1982
BILIRUBIN(TOTAL) DETERMINATION CTMS
K820675 · CIG
Chemistry · 21d
Cleared Apr 01, 1982
DOW BILIRUBIN(DIRECT) DETERMINATION
K820714 · CIG
Chemistry · 17d
Cleared Oct 19, 1981
DIRECT IRON REAGENT SET
K812777 · JIY
Chemistry · 14d
Cleared Jul 15, 1981
QUICK-CHEM COLORIMETER
K811806 · JJQ
Chemistry · 20d
Cleared Apr 14, 1981
CREATINE KINASE MB ISOENZYME IMMUNO UV
K810861 · JHW
Chemistry · 14d
Cleared Mar 31, 1981
AST-UV (PLP-ACTIVATED) DETERMINATION
K810727 · CIT
Chemistry · 14d
Cleared Sep 26, 1980
UV URIC ACID STANDARDS
K801501 · JIS
Chemistry · 91d
Cleared Apr 02, 1980
LIPASE DETERMINATION
K800550 · CFG
Chemistry · 23d
Cleared Aug 03, 1979
KINETIC DETERMINATION OF UV GLUCOSE
K791110 · LFR
Chemistry · 50d
Cleared Jun 28, 1979
UV URIC ACID DETERMINATION
K790834 · CDO
Chemistry · 59d
Cleared Jul 27, 1978
(AST) OR (ALT) UV DETERM. PHY. PHOS.
K781020 · CIT
Chemistry · 42d
Cleared May 26, 1978
ACCESSORY HDL CHOLESTEROL REAGENT SET
K780638 · CHH
Chemistry · 38d
Cleared Nov 22, 1977
UV GLUCOSE DETERM., AUTO CHEM. ANALYZERS
K771102 · LFR
Chemistry · 155d
Cleared Jul 21, 1977
HEMOGLOBIN ANALYZER & PERFORM. CHECK SET
K771101 · GIG
Chemistry · 31d
Cleared Jul 14, 1977
GLUTAMATE OXALACETIC TRANSAMINASE
K770917
Chemistry · 56d
Cleared Jun 02, 1977
CHOLESTEROL REAGENT SET
K770998 · CHH
Chemistry
Cleared Oct 29, 1976
CLINICAL SPECTROPHOTOMETER
K760672 · JJQ
Chemistry · 39d
Cleared Jul 26, 1976
COLORIMETRIC DETERMINATION (SGOT/SGPT)
K760010 · CIT
Chemistry · 46d
Cleared Jul 26, 1976
REAGENT, TRIGLYCERIDES
K760011 · CDT
Chemistry · 46d
Cleared Jul 20, 1976
COLORIMETRIC DETERMINATION (LDH)
K760009 · CFH
Chemistry · 40d
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