Isolab, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
44
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K951014ISOLAB'S T4 TEST KITOctober 18, 1996
K950481NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KITFebruary 1, 1996
K943547PHENYLALANINE TEST KITJanuary 26, 1996
K950803ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 800, 4000 SAMPLESeptember 21, 1995
K950415FLUOROSCAN NEONATALSeptember 5, 1995
K942276QUIK-SEP QUANTITATIVE HEMOGLOBIN S ASSAYJanuary 20, 1995
K942222QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLSJanuary 20, 1995
K944185ISOSCANNovember 17, 1994
K934013RESOLVE SYSTEMS ALKALINE PHOSPHATASE TEST KITApril 26, 1994
K923153HEMOCARD, HEMOGLOBIN C ASSAYJanuary 27, 1994
K931234HEMOCARD CONTROL HB-AA, AE, FAA, FAEMay 11, 1993
K930070HEMOCARD HEMOGLOBIN EApril 8, 1993
K924173HEMOCARD(TM) CONTROLDecember 1, 1992
K921681CRITERION, HEMOCUE B-HEMOGLOBIN CONTROLNovember 17, 1992
K911981HEMOCARD HEMOGLOBIN SOctober 9, 1991
K910430HEMOCARD-ASApril 15, 1991
K910431HEMOCARD CONTROLMarch 11, 1991
K905513GLYC-AFFIN(TM)-GAJanuary 15, 1991
K904814GLYC-AFFIN GPDecember 26, 1990
K902740LDL-DIRECT CONTROLSDecember 7, 1990