Home / 510(k) Clearances / K874875

510(k) K874875

CHEMELIA FREE THYROXINE(FT4)/ENZYME IMMUNO. (EIA) by Boots-Celltech Diagnostics, Inc. — Product Code CEC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 1988
Date Received
November 27, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Free Thyroxine
Device Class
Class II
Regulation Number
862.1695
Review Panel
CH
Submission Type

Other clearances by Boots-Celltech Diagnostics, Inc.

  • K871877 — IDEIA HERPES SIMPLEX VIRUS TEST (November 17, 1989)
  • K880799 — MODIFIED IDEIA CHLAMYDIA TEST (December 8, 1988)
  • K880758 — SUCROSEP SPECIFIC IMMUNORADIOMETRIC ASSAY (April 18, 1988)
  • K872958 — IMAGEN INFLUENZA VIRUS A AND B TESTMI (February 24, 1988)
  • K872843 — OVEIA (TM) DUAL ANALYTE (February 2, 1988)
  • K873625 — CHEMELIA ENZYME IMMUNOASSAY FOR (TSH) (October 20, 1987)
  • K872056 — MODIFIED (DIRECTIONS FOR USE) FOR IDEIA(TM) TEST (June 15, 1987)
  • K870602 — IMAGEN HERPES SIMPLEX VIRUS (HSV) TYPING TEST (May 8, 1987)
  • K864998 — IDEIA(TM) CHLAMYDIA SPECIMEN COLLECTION KIT (April 20, 1987)
  • K864539 — MODIFIED IMAGEN(TM) CHLAMYDIA TEST (March 12, 1987)

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