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510(k) K896864

FOLLICLE STIMULATING HORMONE-EIA-XT by In Vitro Diagnostics, Inc. — Product Code CGJ

K896864 is an FDA 510(k) premarket notification submitted by In Vitro Diagnostics, Inc. for the device "FOLLICLE STIMULATING HORMONE-EIA-XT". The FDA issued a decision of Substantially Equivalent on January 11, 1990. The device falls under product code CGJ (Radioimmunoassay, Follicle-Stimulating Hormone), a Class I device regulated under 21 CFR 862.1300. In Vitro Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 1990
Date Received
December 6, 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 In Vitro Diagnostics, Inc.

  • K896867 — THYROID STIMULATING HORMONE-EIA-XT (February 23, 1990)
  • K896866 — LUTEINIZING HORMONE-EIA-XT (February 13, 1990)
  • K896863 — DIGOXIN-EIA-XT (February 13, 1990)
  • K896865 — VITRO T4-EIA-XT (January 30, 1990)
  • K896925 — T UPTAKE ENZYME IMMUNOASSAY CRIMPED TUBE KIT (January 18, 1990)
  • K873832 — REAGENTS FOR USE ON CONTRAVES DC300, DC500, AL801 (November 23, 1987)
  • K871187 — LITHIUM INTERNAL STANDARD 3000 MEQ/L #60084 (May 28, 1987)
  • K871185 — LITHIUM INTERNAL STANDARD 1 MEQ/L #60085 (May 28, 1987)
  • K871183 — FLAME PHOTOMETER STANDARD #60082 140 NA/5K (May 28, 1987)
  • K871186 — CESIUM DILUENT 1.5 MMOL CS/L #60087 (May 28, 1987)

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