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Boots-Celltech Diagnostics, Inc.

FDA 510(k) & PMA Approved Devices — 20 products

Total Devices20
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K871877 IDEIA HERPES SIMPLEX VIRUS TESTLGC1989-11-17 View
510(k) K880799 MODIFIED IDEIA CHLAMYDIA TESTLJC1988-12-08 View
510(k) K880758 SUCROSEP SPECIFIC IMMUNORADIOMETRIC ASSAYCEP1988-04-18 View
510(k) K874875 CHEMELIA FREE THYROXINE(FT4)/ENZYME IMMUNO. (EIA)CEC1988-03-24 View
510(k) K872958 IMAGEN INFLUENZA VIRUS A AND B TESTMIGNX1988-02-24 View
510(k) K872843 OVEIA (TM) DUAL ANALYTEJLP1988-02-02 View
510(k) K873625 CHEMELIA ENZYME IMMUNOASSAY FOR (TSH)JLM1987-10-20 View
510(k) K872056 MODIFIED (DIRECTIONS FOR USE) FOR IDEIA(TM) TESTLJC1987-06-15 View
510(k) K870602 IMAGEN HERPES SIMPLEX VIRUS (HSV) TYPING TESTGQN1987-05-08 View
510(k) K864998 IDEIA(TM) CHLAMYDIA SPECIMEN COLLECTION KITJSM1987-04-20 View
510(k) K864539 MODIFIED IMAGEN(TM) CHLAMYDIA TESTLJP1987-03-12 View
510(k) K862439 SUCROSEP FOLLICLE STIMULATING HORMONE (FSH) IRMACGJ1986-08-19 View
510(k) K861966 MODIFIED IDEIA CHLAMYDIA TESTLJC1986-08-19 View
510(k) K862607 IMAGEN(TM) CHLAMYDIA SPECIMEN COLLECTION KITLIO1986-08-04 View
510(k) K861271 SUCROSEP HUMAN PROLACTIN (HPR) IRMACFT1986-06-27 View
510(k) K860308 SUCROSEP LUTEINIZING HORMONE (LH) IRMACEP1986-03-17 View
510(k) K860228 SUCROSEP HUMAN GROWTH HORMONE (HGH) IRMACFL1986-02-28 View
510(k) K854081 IMAGEN RESPIRATORY SYNCYTIAL VIRUS TESTGQG1986-01-03 View
510(k) K844683 IMAGEN CHLAMYDIA TESTIWP1985-02-06 View
510(k) K842593 SUCROSEP THYROID STIMULATING HORMONEJLW1984-09-12 View
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