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510(k) K964424

ROTAVIRUS EIA by Trinity Biotech, Inc. — Product Code LIQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 1997
Date Received
November 5, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Linked Immunoabsorbent Assay, Rotavirus
Device Class
Class I
Regulation Number
866.3405
Review Panel
MI
Submission Type

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  • K951208 — ROTA-DAN RAPID ROTAVIRUS EIA KIT (February 14, 1996)
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  • K932384 — IDEIA(TM) ROTAVIRUS (December 27, 1993)
  • K915137 — KALLESTAD ROTAVIRUS MICROPLATE (March 4, 1992)
  • K912666 — DAKO ELISA ROTAVIRUS KIT- 96 TESTS K440 (February 14, 1992)