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510(k) K873565

SNAP(R) ROTAVIRUS DIAGNOSTIC KIT by Molecular Biosystems, Inc. — Product Code LIO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 1988
Date Received
September 2, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Specimen Collection
Device Class
Class I
Regulation Number
866.2900
Review Panel
MI
Submission Type

Other clearances by Molecular Biosystems, Inc.

  • K874544 — SNAP(R) CAMPYLOBACTER CULTURE IDENT DIAGNOSTIC KIT (August 12, 1988)
  • K873670 — SNAP CAMPYLOBACTOR DIAGNOSTIC KIT (June 8, 1988)
  • K873932 — THE EXTRACTOR(TM) (November 20, 1987)

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