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510(k) K972720

FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300) by Monobind — Product Code CGJ

K972720 is an FDA 510(k) premarket notification submitted by Monobind for the device "FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300)". The FDA issued a decision of Substantially Equivalent on September 2, 1997. The device falls under product code CGJ (Radioimmunoassay, Follicle-Stimulating Hormone), a Class I device regulated under 21 CFR 862.1300. Monobind has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 1997
Date Received
July 21, 1997
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 Monobind

  • K181017 — Free Testosterone AccuBind ELISA Test System (July 20, 2018)
  • K063437 — ACCUBIND NEO-TSH MICROWELL ELISA, MODEL 3425-300 (April 4, 2008)
  • K030860 — ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300 (August 22, 2003)
  • K020548 — FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300 (April 5, 2002)
  • K980088 — T-UPTAKE MICROPLATE EIA (February 4, 1998)
  • K971834 — ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA (July 3, 1997)
  • K971835 — ANTI-THYROGLOBULIN (TG) MICROPLATE ELISA (July 3, 1997)
  • K971921 — PROLACTIN (PRL) HORMONE MICROPLATE ELISA (June 24, 1997)
  • K971780 — THYROTROPIN(TSH) ELISA (June 24, 1997)
  • K971779 — TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIA (June 16, 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)
  • 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)
  • K962118 — DSL ACTIVE FSH IRMA (September 9, 1996)

FDA data resources