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510(k) K970483

AQUALITE INTACT PTH by Sealite Sciences, Inc. — Product Code CEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 1997
Date Received
February 10, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Parathyroid Hormone
Device Class
Class II
Regulation Number
862.1545
Review Panel
CH
Submission Type

Other clearances by Sealite Sciences, Inc.

  • K974551 — SEALITE SCIENCES, INC. AQUALITE FREE T, ASSAY (December 22, 1997)
  • K972761 — SEALITE SCIENCES, INC. AQUALITE HUMAN GROWTH HORMONE ASSAY (September 25, 1997)
  • K970612 — SEALITE SCIENCES, INC. AQUALITE FERRITIN ASSAY (June 24, 1997)
  • K970188 — SEALITE SCIENCES, INC. AQUALITE PROLACTIN (February 20, 1997)
  • K970085 — SEALITE SCIENCES AQUALITE FSH (February 14, 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)

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