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510(k) K952285

AMERLITE FSH ASSAY by Johnson & Johnson Clinical Diagnostics, Inc. — Product Code CGJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 1995
Date Received
May 16, 1995
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 Johnson & Johnson Clinical Diagnostics, Inc.

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  • K973517 — VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS (September 25, 1997)
  • K973030 — VITROS IMMUNODIAGNOSTICS PRODUCTS/CK-MB REAGENT PACK(GEM.1300)/CK-MB CALIBRATORS (September 4, 1997)
  • K972133 — VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTE (June 24, 1997)
  • K970894 — VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL B-HCG REAGENT PACK (GEM.1075), TOTAL B-H (April 14, 1997)
  • K970643 — VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CA (March 18, 1997)
  • K965142 — VITROS IMMUNODIAGNOSTICS PRODUCTS FREE T4 REAGENT PACK (GEM.1015) FREE T4 CALIBR (March 18, 1997)
  • K970281 — VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS (February 25, 1997)
  • K964982 — VITROS IMMUNODIAGNOSTICS PRODUCTS LH REAGENT PACK (GEM.1055) AND LH CALIBRATORS (February 20, 1997)

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)