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510(k) K892706

SR1 (FSH) IMMUNOENZYMETRIC ASSAY by Serono-Baker Diagnostics, Inc. — Product Code CGJ

K892706 is an FDA 510(k) premarket notification submitted by Serono-Baker Diagnostics, Inc. for the device "SR1 (FSH) IMMUNOENZYMETRIC ASSAY". The FDA issued a decision of Substantially Equivalent on Jun 9, 1989. The device falls under product code CGJ (Radioimmunoassay, Follicle-Stimulating Hormone), a Class I device regulated under 21 CFR 862.1300. Serono-Baker Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jun 9, 1989
Date Received
Apr 14, 1989
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 Serono-Baker Diagnostics, Inc.

  • K924257 — TESTOSTERONE SEROZYME(TM) ENZYME IMMUNOASSAY (Nov 30, 1992)
  • K915164 — SRI TESTOSTERONE ENZYME IMMUNOASSAY (Mar 2, 1992)
  • K914886 — SRI(TM) CORTISOL ENZYME IMMUNOASSAY(MAG SOL PHASE) (Mar 2, 1992)
  • K915602 — SRI DIGOXIN ENZYME IMMUNOASSAY (Jan 17, 1992)
  • K912937 — SR1 FREE T4 ENZYME IMMUNOASSAY (Nov 19, 1991)
  • K914462 — SRI PROGESTERONE ENZYME IMMUNOASSAY(MAG SOLD PHAS) (Oct 23, 1991)
  • K911912 — SR1 T3 UPTAKE ENZYME IMMUNOASSAY(MAG SOLID-PHASE) (Sep 18, 1991)
  • K911217 — SR1 T4 ENZYME IMMUNOASSAY (MAGNETIC SOLID-PHASE) (Aug 16, 1991)
  • K912318 — ESTRADIOL SEROZYME ENZYME IMMUNO (MAG SOLID-PHASE) (Jul 25, 1991)
  • K911396 — SR1 ESTRADIOL ENZYME IMMUNOASSAY (May 28, 1991)

Other clearances for product code CGJ

  • K052662 — ONE STEP FSH MENOPAUSAL TEST (Nov 30, 2005)
  • K043599 — MOMENTS MENOPAUSE CHECK, MODEL 9113 (Feb 25, 2005)
  • K041165 — FSH MENOPAUSE PREDICTOR TEST (Jun 17, 2004)
  • K040575 — PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112 (May 20, 2004)
  • K030058 — EARLYDETECT MENOPAUSE TEST FOR FSH (Jul 30, 2003)
  • K002450 — GENUA MENOPAUSE MONITOR TEST KIT (Jan 12, 2001)
  • K972720 — FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300) (Sep 2, 1997)
  • K970085 — SEALITE SCIENCES AQUALITE FSH (Feb 14, 1997)
  • K964720 — VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS ( (Feb 4, 1997)
  • K964693 — ELECSYS FSH ASSAY (Dec 16, 1996)

FDA data resources