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510(k) K921746

VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM by Biomerieux Vitek, Inc. — Product Code CGJ

K921746 is an FDA 510(k) premarket notification submitted by Biomerieux Vitek, Inc. for the device "VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM". The FDA issued a decision of Substantially Equivalent on June 16, 1992. The device falls under product code CGJ (Radioimmunoassay, Follicle-Stimulating Hormone), a Class I device regulated under 21 CFR 862.1300. Biomerieux Vitek, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 1992
Date Received
April 13, 1992
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 Biomerieux Vitek, Inc.

  • K973819 — VIDAS D-DIMER (DD) ASSAY (March 10, 1998)
  • K972895 — VIDAS ROTAVIRUS (RTV) ASSAY (October 3, 1997)
  • K965092 — VIDAS ROTAVIRUS ASSAY (May 5, 1997)
  • K964887 — VIDAS C. DIFFICILE TOXIN A II ASSAY (April 8, 1997)
  • K955627 — VIDAS CHLAMYDIA BLOCKING ASSAY (October 7, 1996)
  • K962549 — VIDAS CREATINE KINASE MB ASSAY 30-421 (August 30, 1996)
  • K962609 — GRAM NEGATIVE IDENTIFICATION PLUS CARD (August 30, 1996)
  • K952095 — VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI) (March 12, 1996)
  • K955647 — VIDAS ESTRADIOL II (E2II) ASSAY (February 6, 1996)
  • K943812 — VIDAS LYME SCREEN II (June 13, 1995)

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