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510(k) K872843

OVEIA (TM) DUAL ANALYTE by Boots-Celltech Diagnostics, Inc. — Product Code JLP

K872843 is an FDA 510(k) premarket notification submitted by Boots-Celltech Diagnostics, Inc. for the device "OVEIA (TM) DUAL ANALYTE". The FDA issued a decision of Substantially Equivalent on February 2, 1988. The device falls under product code JLP (Spectrophotometric Method, Pregnanediol), a Class I device regulated under 21 CFR 862.1605. Boots-Celltech Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 1988
Date Received
July 20, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spectrophotometric Method, Pregnanediol
Device Class
Class I
Regulation Number
862.1605
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)
  • K874875 — CHEMELIA FREE THYROXINE(FT4)/ENZYME IMMUNO. (EIA) (March 24, 1988)
  • K872958 — IMAGEN INFLUENZA VIRUS A AND B TESTMI (February 24, 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)

FDA data resources