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510(k) K083464

PREMIER CAMPY, MODEL 618096 by Meridian Bioscience, Inc. — Product Code LQP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 2009
Date Received
November 24, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Campylobacter Spp.
Device Class
Class I
Regulation Number
866.3110
Review Panel
MI
Submission Type

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Other clearances for product code LQP

  • K210976 — Curian Campy (December 23, 2021)
  • K211342 — Sofia 2 Campylobacter FIA (November 23, 2021)
  • K191456 — Campylobacter Quik Chek (June 20, 2019)
  • K191442 — Campylobacter Chek (June 20, 2019)
  • K173219 — CAMPYLOBACTER CHEK (January 22, 2018)
  • K173217 — CAMPYLOBACTER QUIK CHEK (January 22, 2018)
  • K090700 — IMMUNOCARD STAT CAMPY, MODEL 751530 (May 28, 2009)
  • K982315 — PROSPECT CAMPYLOBACTER MICROPLATE ASSAY (November 18, 1998)
  • K880389 — MERITEC(TM)-CAMPY (JCL) (April 12, 1988)
  • K864027 — BBL CAMPYSLIDE(TM) TEST (December 11, 1986)