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510(k) K862439

SUCROSEP FOLLICLE STIMULATING HORMONE (FSH) IRMA by Boots-Celltech Diagnostics, Inc. — Product Code CGJ

K862439 is an FDA 510(k) premarket notification submitted by Boots-Celltech Diagnostics, Inc. for the device "SUCROSEP FOLLICLE STIMULATING HORMONE (FSH) IRMA". The FDA issued a decision of Substantially Equivalent on August 19, 1986. The device falls under product code CGJ (Radioimmunoassay, Follicle-Stimulating Hormone), a Class I device regulated under 21 CFR 862.1300. Boots-Celltech Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 1986
Date Received
June 26, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Follicle-Stimulating Hormone
Device Class
Class I
Regulation Number
862.1300
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)
  • 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)

Other clearances for product code CGJ

  • K052662 — ONE STEP FSH MENOPAUSAL TEST (November 30, 2005)
  • K043599 — MOMENTS MENOPAUSE CHECK, MODEL 9113 (February 25, 2005)
  • K041165 — FSH MENOPAUSE PREDICTOR TEST (June 17, 2004)
  • K040575 — PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112 (May 20, 2004)
  • K030058 — EARLYDETECT MENOPAUSE TEST FOR FSH (July 30, 2003)
  • K002450 — GENUA MENOPAUSE MONITOR TEST KIT (January 12, 2001)
  • K972720 — FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300) (September 2, 1997)
  • K970085 — SEALITE SCIENCES AQUALITE FSH (February 14, 1997)
  • K964720 — VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS ( (February 4, 1997)
  • K964693 — ELECSYS FSH ASSAY (December 16, 1996)

FDA data resources