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Diagnostic Systems

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
14
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K905146OLYMPUS URINE PHFebruary 4, 1991
K893691EMDS CREATINE KINASE ITEM NIMBER 65411August 31, 1989
K893692EMDS ASPARTATE AMINOTRANSFERASE ITEM NUMBER 65405August 21, 1989
K893966HDL PRECIPITATING REAGENTJuly 25, 1989
K884993VISUAL BLOOD GLUCOSE TEST SYSTEMDecember 29, 1988
K881116EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641June 20, 1988
K880787EASY-TEST LACTIC ACID (LA)March 15, 1988
K862403EMDS ANTIEPILEPTIC DRUG CALIBRATORS ITEM #67630/95July 11, 1986
K854784ABSORBANCE (ABS) TEST PAKDecember 19, 1985
K853699EASY ANALYZER & EASY-TEST REAGENTSeptember 25, 1985
K853533ABSORBANCE TEST SOLUTIONSeptember 16, 1985
K853532ALCOHOL CALIBRATORSSeptember 16, 1985
K830816DSL 1900April 12, 1983
K830700MMH PTH RIA KITApril 6, 1983