The Dow Chemical Co.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
26
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K823474ENZYMATIC GLUCOSE DETERMINATIONDecember 30, 1982
K822154UREA NITROGEN (ENZYMATIC) DETERMINATIONAugust 5, 1982
K821536DOWFLOW ALT-UV DETERMINATIONJune 14, 1982
K821315DOWFLOW ENZYMATIC TRIGLYCERIDES DETERMMay 24, 1982
K820714DOW BILIRUBIN(DIRECT) DETERMINATIONApril 1, 1982
K820675BILIRUBIN(TOTAL) DETERMINATION CTMSApril 1, 1982
K812777DIRECT IRON REAGENT SETOctober 19, 1981
K811806QUICK-CHEM COLORIMETERJuly 15, 1981
K810861CREATINE KINASE MB ISOENZYME IMMUNO UVApril 14, 1981
K810727AST-UV (PLP-ACTIVATED) DETERMINATIONMarch 31, 1981
K801501UV URIC ACID STANDARDSSeptember 26, 1980
K800550LIPASE DETERMINATIONApril 2, 1980
K791110KINETIC DETERMINATION OF UV GLUCOSEAugust 3, 1979
K790834UV URIC ACID DETERMINATIONJune 28, 1979
K781020(AST) OR (ALT) UV DETERM. PHY. PHOS.July 27, 1978
K780638ACCESSORY HDL CHOLESTEROL REAGENT SETMay 26, 1978
K771102UV GLUCOSE DETERM., AUTO CHEM. ANALYZERSNovember 22, 1977
K771101HEMOGLOBIN ANALYZER & PERFORM. CHECK SETJuly 21, 1977
K770917GLUTAMATE OXALACETIC TRANSAMINASEJuly 14, 1977
K770940TOTAL THYROXINE (RIA) REAGENT SETJune 22, 1977