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510(k) K921704

IMMULITE(R) FSH by Cirrus Diagnostics, Inc. — Product Code CGJ

K921704 is an FDA 510(k) premarket notification submitted by Cirrus Diagnostics, Inc. for the device "IMMULITE(R) FSH". The FDA issued a decision of Substantially Equivalent on June 9, 1992. The device falls under product code CGJ (Radioimmunoassay, Follicle-Stimulating Hormone), a Class I device regulated under 21 CFR 862.1300. Cirrus Diagnostics, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 1992
Date Received
April 10, 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 Cirrus Diagnostics, Inc.

  • K920411 — IMMULITE HLH (March 11, 1992)
  • K914833 — IMMULITE DIGOXIN (November 22, 1991)
  • K911796 — IMMULITE(TM) HCG (June 20, 1991)
  • K910677 — IMMULITE(TM) T-UPTAKE (April 29, 1991)
  • K910261 — IMMULITE(TM) TOTAL T4 (April 16, 1991)
  • K905648 — CRP LIPID REAGENT TEST PACK (March 6, 1991)
  • K905214 — IMMULITE (TM) TOTAL T3 (February 1, 1991)
  • K905769 — IMMULITE HS-TSH (January 31, 1991)
  • K905215 — IMMULITE (TM) AUTOMATED IMMUNOASSAY ANALYZER (January 11, 1991)

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