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510(k) K940005

ACCESS HUMAN FOLLICLE STIMULATING HORMONE ASSAY by Bio-Rad Laboratories, Inc. — Product Code CGJ

K940005 is an FDA 510(k) premarket notification submitted by Bio-Rad Laboratories, Inc. for the device "ACCESS HUMAN FOLLICLE STIMULATING HORMONE ASSAY". The FDA issued a decision of Substantially Equivalent on March 3, 1994. The device falls under product code CGJ (Radioimmunoassay, Follicle-Stimulating Hormone), a Class I device regulated under 21 CFR 862.1300. Bio-Rad Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 1994
Date Received
January 3, 1994
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

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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