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510(k) K873670

SNAP CAMPYLOBACTOR DIAGNOSTIC KIT by Molecular Biosystems, Inc. — Product Code LQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 1988
Date Received
September 11, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dna-Reagents, Campylobacter Spp.
Device Class
Class I
Regulation Number
866.3110
Review Panel
MI
Submission Type

Other clearances by Molecular Biosystems, Inc.

  • K874544 — SNAP(R) CAMPYLOBACTER CULTURE IDENT DIAGNOSTIC KIT (August 12, 1988)
  • K873565 — SNAP(R) ROTAVIRUS DIAGNOSTIC KIT (May 13, 1988)
  • K873932 — THE EXTRACTOR(TM) (November 20, 1987)

Other clearances for product code LQO

  • K894712 — ACCUPROBE CAMPYLOBACTER CULTURE CONFIRMATION (November 14, 1989)
  • K875101 — VIROGEN CMV ANTIBODY TEST (March 1, 1988)
  • K863270 — GENE-TRAK CAMPYLOBACTER ASSAY (August 31, 1987)