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510(k) K821611

GAMMADAB [125] FSH RADIOIMMUNAY KIT by Clinical Assays, Inc. — Product Code CGJ

K821611 is an FDA 510(k) premarket notification submitted by Clinical Assays, Inc. for the device "GAMMADAB [125] FSH RADIOIMMUNAY KIT". The FDA issued a decision of Substantially Equivalent on June 24, 1982. The device falls under product code CGJ (Radioimmunoassay, Follicle-Stimulating Hormone), a Class I device regulated under 21 CFR 862.1300. Clinical Assays, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1982
Date Received
June 2, 1982
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 Clinical Assays, Inc.

  • K832710 — VITAMIN B12 RADIOASSAY KIT CA-1534 (October 4, 1983)
  • K832712 — FOLATE RADIOASSAY KIT CA-1562-125 (October 4, 1983)
  • K832711 — VITAMIN B12 FOLATE CA-1515-125 (October 4, 1983)
  • K823476 — GAMMADAB LH RADIO-KIT #CA-1508 (December 28, 1982)
  • K823313 — IN VITRO GAMMACOAT B-HCG RADIO. TEST (December 22, 1982)
  • K821092 — GAMMADAB[125]EGE RADIOIMMUNOASSAY IT (June 22, 1982)
  • K812227 — GAMMACOAT (125) INSULIN RADIOIMMUNOASSAY (September 24, 1981)
  • K810722 — GASTRIN RADIOIMMUNOASSAY TEST (May 27, 1981)
  • K810967 — IN-VITRO TBG RADIOIMMUNOASSAY TEST (April 23, 1981)
  • K801667 — GAMMA COAT(125 I) RUBELLA ANTIBODY (October 23, 1980)

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