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510(k) K052662

ONE STEP FSH MENOPAUSAL TEST by Ind Diagnostic, Inc. — Product Code CGJ

K052662 is an FDA 510(k) premarket notification submitted by Ind Diagnostic, Inc. for the device "ONE STEP FSH MENOPAUSAL TEST". The FDA issued a decision of Substantially Equivalent on November 30, 2005. The device falls under product code CGJ (Radioimmunoassay, Follicle-Stimulating Hormone), a Class I device regulated under 21 CFR 862.1300. Ind Diagnostic, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 2005
Date Received
September 27, 2005
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 Ind Diagnostic, Inc.

  • K103037 — IND URINARY TRACT INFECTION (UTI) TEST STRIPS (April 17, 2012)
  • K100031 — IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10 (July 19, 2010)
  • K063390 — URINE CHEMISTRY ANALYZER UR-50 (March 1, 2007)
  • K060810 — ONE STEP DRUG TEST - AMP/MET/MOR/THC/COC (August 7, 2006)
  • K052694 — ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES. (December 16, 2005)
  • K050741 — IND ONE STEP HCG PREGNANCY TEST - CASSETTE FORMAT (May 16, 2005)
  • K023638 — CASSETTE/URINE HCG (January 3, 2003)

Other clearances for product code CGJ

  • 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)
  • K962118 — DSL ACTIVE FSH IRMA (September 9, 1996)

FDA data resources