Diagnostic Systems

FDA Regulatory Profile

Diagnostic Systems appears in FDA public data with 0 recalls, 14 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on Feb 4, 1991.

Summary

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

Recent 510(k) Clearances

K-NumberDeviceDate
K905146OLYMPUS URINE PHFeb 4, 1991
K893691EMDS CREATINE KINASE ITEM NIMBER 65411Aug 31, 1989
K893692EMDS ASPARTATE AMINOTRANSFERASE ITEM NUMBER 65405Aug 21, 1989
K893966HDL PRECIPITATING REAGENTJul 25, 1989
K884993VISUAL BLOOD GLUCOSE TEST SYSTEMDec 29, 1988
K881116EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641Jun 20, 1988
K880787EASY-TEST LACTIC ACID (LA)Mar 15, 1988
K862403EMDS ANTIEPILEPTIC DRUG CALIBRATORS ITEM #67630/95Jul 11, 1986
K854784ABSORBANCE (ABS) TEST PAKDec 19, 1985
K853699EASY ANALYZER & EASY-TEST REAGENTSep 25, 1985
K853533ABSORBANCE TEST SOLUTIONSep 16, 1985
K853532ALCOHOL CALIBRATORSSep 16, 1985
K830816DSL 1900Apr 12, 1983
K830700MMH PTH RIA KITApr 6, 1983