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510(k) K173219

CAMPYLOBACTER CHEK by Techlab, Inc. — Product Code LQP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 2018
Date Received
October 3, 2017
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

Other clearances by Techlab, Inc.

  • K191456 — Campylobacter Quik Chek (June 20, 2019)
  • K191442 — Campylobacter Chek (June 20, 2019)
  • K181400 — H. PYLORI CHEK™ (August 21, 2018)
  • K181379 — H. PYLORI QUIK CHEK (August 21, 2018)
  • K173217 — CAMPYLOBACTER QUIK CHEK (January 22, 2018)
  • K171078 — TRI-COMBO PARASITE SCREEN (July 10, 2017)
  • K170728 — E. HISTOLYTICA QUIK CHEK (June 7, 2017)
  • K082499 — C. DIFF QUIK CHEK COMPLETE (March 26, 2009)
  • K053572 — C. DIFF QUIK CHEK (April 26, 2006)
  • K051927 — TECHLAB ASCA-CHEK (April 6, 2006)

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)
  • K173217 — CAMPYLOBACTER QUIK CHEK (January 22, 2018)
  • K090700 — IMMUNOCARD STAT CAMPY, MODEL 751530 (May 28, 2009)
  • K083464 — PREMIER CAMPY, MODEL 618096 (January 30, 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)