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510(k) K942286

DIARLEX ROTA-ADENO by Orion Diagnostica, Inc. — Product Code LIQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 1994
Date Received
April 22, 1994
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)
  • K933587 — IMMUNOCARD ROTAVIRUS (February 3, 1994)
  • 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)