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510(k) K863270

GENE-TRAK CAMPYLOBACTER ASSAY by Integrated Genetics — Product Code LQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 1987
Date Received
August 25, 1986
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 for product code LQO

  • K894712 — ACCUPROBE CAMPYLOBACTER CULTURE CONFIRMATION (November 14, 1989)
  • K873670 — SNAP CAMPYLOBACTOR DIAGNOSTIC KIT (June 8, 1988)
  • K875101 — VIROGEN CMV ANTIBODY TEST (March 1, 1988)