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510(k) K970085

SEALITE SCIENCES AQUALITE FSH by Sealite Sciences, Inc. — Product Code CGJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 1997
Date Received
January 10, 1997
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

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  • K970612 — SEALITE SCIENCES, INC. AQUALITE FERRITIN ASSAY (June 24, 1997)
  • K970483 — AQUALITE INTACT PTH (April 14, 1997)
  • K970188 — SEALITE SCIENCES, INC. AQUALITE PROLACTIN (February 20, 1997)
  • K964925 — SEALITE SCIENCES, INC. AQUALITE LH (January 22, 1997)
  • K942661 — AQUALITE TSH BIOLUMINESCENT IMMUNOASSAY KIT (January 17, 1995)
  • K943437 — AQUALITE FSH (December 28, 1994)
  • K943188 — SEALITE SCIENCE, INC. AQUALITE(R) LH (October 20, 1994)
  • K941983 — SEALITE SCIENCES INC. (August 18, 1994)

Other clearances for product code CGJ

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  • 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)
  • 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)