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Boots-Celltech Diagnostics, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
20
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K871877IDEIA HERPES SIMPLEX VIRUS TESTNovember 17, 1989
K880799MODIFIED IDEIA CHLAMYDIA TESTDecember 8, 1988
K880758SUCROSEP SPECIFIC IMMUNORADIOMETRIC ASSAYApril 18, 1988
K874875CHEMELIA FREE THYROXINE(FT4)/ENZYME IMMUNO. (EIA)March 24, 1988
K872958IMAGEN INFLUENZA VIRUS A AND B TESTMIFebruary 24, 1988
K872843OVEIA (TM) DUAL ANALYTEFebruary 2, 1988
K873625CHEMELIA ENZYME IMMUNOASSAY FOR (TSH)October 20, 1987
K872056MODIFIED (DIRECTIONS FOR USE) FOR IDEIA(TM) TESTJune 15, 1987
K870602IMAGEN HERPES SIMPLEX VIRUS (HSV) TYPING TESTMay 8, 1987
K864998IDEIA(TM) CHLAMYDIA SPECIMEN COLLECTION KITApril 20, 1987
K864539MODIFIED IMAGEN(TM) CHLAMYDIA TESTMarch 12, 1987
K862439SUCROSEP FOLLICLE STIMULATING HORMONE (FSH) IRMAAugust 19, 1986
K861966MODIFIED IDEIA CHLAMYDIA TESTAugust 19, 1986
K862607IMAGEN(TM) CHLAMYDIA SPECIMEN COLLECTION KITAugust 4, 1986
K861271SUCROSEP HUMAN PROLACTIN (HPR) IRMAJune 27, 1986
K860308SUCROSEP LUTEINIZING HORMONE (LH) IRMAMarch 17, 1986
K860228SUCROSEP HUMAN GROWTH HORMONE (HGH) IRMAFebruary 28, 1986
K854081IMAGEN RESPIRATORY SYNCYTIAL VIRUS TESTJanuary 3, 1986
K844683IMAGEN CHLAMYDIA TESTFebruary 6, 1985
K842593SUCROSEP THYROID STIMULATING HORMONESeptember 12, 1984