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Clark Laboratories, Inc.

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
14
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0382-2022Class IIBartels Legionella Urinary Antigen- an adjunct to culture for the presumptive diagnosis of past or cOctober 11, 2021
Z-1503-2021Class IITrinity Biotech Captia Measles IgM Kit, Catalog No. 2326060 - Product Usage: intended for the qualitMarch 17, 2021

Recent 510(k) Clearances

K-NumberDeviceDate
K980596VCA IGM ELISA TEST SYSTEMJuly 22, 1998
K980912VCA IGG ELISA TEST SYSTEMJuly 22, 1998
K980598EBNA-1 IGM ELISA TEST SYSTEMMay 1, 1998
K973123EA-D IGG ELISA TEST SYSTEMMarch 26, 1998
K931543ENCORE ENA COMBINED EIASeptember 8, 1993
K925826ENCORE THYROGLOBULIN IGE, IGA AND IGM EIAJanuary 26, 1993
K923537ENCORE DS-DNADecember 23, 1992
K921870ENCORE SM/RNPDecember 1, 1992
K921572ENCORE SMDecember 1, 1992
K922340ENCORE SS-BOctober 16, 1992
K922157ENCORE SS-AOctober 13, 1992
K924056ENCORE RHEUMATOID FACTOR EIASeptember 25, 1992
K921573RUBELLA IGMAugust 27, 1992
K920150ENCORE SCL-70March 18, 1992