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510(k) K820358

FOLLICLE STIMULATING HORMONE KIT by Pcl-Ria, Inc. — Product Code CGJ

K820358 is an FDA 510(k) premarket notification submitted by Pcl-Ria, Inc. for the device "FOLLICLE STIMULATING HORMONE KIT". The FDA issued a decision of Substantially Equivalent on March 26, 1982. The device falls under product code CGJ (Radioimmunoassay, Follicle-Stimulating Hormone), a Class I device regulated under 21 CFR 862.1300. Pcl-Ria, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 1982
Date Received
February 9, 1982
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 Pcl-Ria, Inc.

  • K830526 — B-GCG SYSTEM BY RIA (April 5, 1983)
  • K822935 — THYROID STIMULATING HORMONE (November 1, 1982)
  • K823014 — DIGOXIN KIT (November 1, 1982)
  • K822612 — T3 UPTAKE KITS (September 30, 1982)
  • K820886 — THYROXINE T4 KIT (April 16, 1982)
  • K820357 — LUTEINIZING HORMONE KIT (March 25, 1982)
  • K812666 — THYROXINE (T4) 125I (October 2, 1981)
  • K810867 — FOLLICLE STIMULATING HORMONE (FSH) (April 14, 1981)
  • K810852 — FOLLICLE STIMULATING HORMONE ANTISERUM (April 8, 1981)
  • K810741 — LUTEINIZING HORMONE (March 31, 1981)

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