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510(k) K970612

SEALITE SCIENCES, INC. AQUALITE FERRITIN ASSAY by Sealite Sciences, Inc. — Product Code DBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1997
Date Received
February 18, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ferritin, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5340
Review Panel
IM
Submission Type

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  • K970483 — AQUALITE INTACT PTH (April 14, 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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