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510(k) K905814

LUMATAG(R) FSH CHEMILUMINESCENCE IMMUNOMETRI ASSAY by London Diagnostics, Inc. — Product Code CGJ

K905814 is an FDA 510(k) premarket notification submitted by London Diagnostics, Inc. for the device "LUMATAG(R) FSH CHEMILUMINESCENCE IMMUNOMETRI ASSAY". The FDA issued a decision of Substantially Equivalent on February 4, 1991. The device falls under product code CGJ (Radioimmunoassay, Follicle-Stimulating Hormone), a Class I device regulated under 21 CFR 862.1300. London Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1991
Date Received
December 28, 1990
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 London Diagnostics, Inc.

  • K914835 — LUMATAG FREE T4 CHEMILUMINESCENCE ASSAY (December 17, 1991)
  • K911985 — LUMATAG T4 CHEMILUMINESCENCE ASSAY (August 2, 1991)
  • K912858 — LONDON DIAGNOSTICS LUMATAG(R) HGH CHEM IMMUN ASSAY (July 30, 1991)
  • K904458 — LUMATAG(TM) PROLACTIN DIAGNOSTIC KIT/MODIFICATION (October 12, 1990)
  • K903130 — LONDON DIAGNOSTICS LUMATAG(TM) INTACT PTH ASSAY (September 25, 1990)
  • K903195 — LONDON DIAGNOSTICS LUMATAG (R) IGE CHEM. IMM ASSAY (August 2, 1990)
  • K902443 — LUMATAG(TM) LH DIAGNOSTIC KIT (August 2, 1990)
  • K901484 — LUMATAG(TM) HCG CHEMILUMINESCENCE IMMUNOMETRIC (May 1, 1990)
  • K901075 — LUMATAG(TM) FERRITIN CHEMILUMINESCENCE IMMUNOMET. (April 2, 1990)
  • K881443 — LUMATAG(TM) TSH CHEMILUMINESCENCE IMMUNO. ASSAY (May 27, 1988)

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