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510(k) K920917

ELISA TUBE FSH TEST KIT ENZYME LINKED IMMUN. ASSAY by Bio Clinic Co. — Product Code CGJ

K920917 is an FDA 510(k) premarket notification submitted by Bio Clinic Co. for the device "ELISA TUBE FSH TEST KIT ENZYME LINKED IMMUN. ASSAY". The FDA issued a decision of Substantially Equivalent on March 26, 1992. The device falls under product code CGJ (Radioimmunoassay, Follicle-Stimulating Hormone), a Class I device regulated under 21 CFR 862.1300. Bio Clinic Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 1992
Date Received
February 28, 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 Bio Clinic Co.

  • K930791 — AMERICAN POWER CONVERSIONS, BACK-UPS 600 (August 6, 1993)
  • K932480 — PRISM (July 21, 1993)
  • K926189 — ORTHODERM CONSUMMATE AIR THERAPY BED W/SCALE (June 24, 1993)
  • K921958 — ELISA TUBE TSH TEST (July 2, 1992)
  • K922140 — ORTHODERM CONVERTIBLE II (May 27, 1992)
  • K921212 — MIRCO ELISA HPL TEST KIT (May 7, 1992)
  • K921211 — NOW PREGNANCY TEST KIT (May 7, 1992)
  • K920920 — ELISA TUBE LH TEST KIT (April 8, 1992)
  • K920921 — ELISA TUBE PROLACTIN TEST KIT (April 8, 1992)
  • K920918 — TMB CHROMOGEN/SUBSTRATE REAGENT SET (April 7, 1992)

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