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510(k) K964925

SEALITE SCIENCES, INC. AQUALITE LH by Sealite Sciences, Inc. — Product Code CEP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 1997
Date Received
December 9, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Luteinizing Hormone
Device Class
Class I
Regulation Number
862.1485
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)
  • K970085 — SEALITE SCIENCES AQUALITE FSH (February 14, 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)

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