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510(k) K191442

Campylobacter Chek by Techlab, Inc. — Product Code LQP

K191442 is an FDA 510(k) premarket notification submitted by Techlab, Inc. for the device "Campylobacter Chek". The FDA issued a decision of Substantially Equivalent on June 20, 2019. The device falls under product code LQP (Campylobacter Spp.), a Class I device regulated under 21 CFR 866.3110. Techlab, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2019
Date Received
May 30, 2019
Clearance Type
Special
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)
  • K181400 — H. PYLORI CHEK™ (August 21, 2018)
  • K181379 — H. PYLORI QUIK CHEK (August 21, 2018)
  • K173219 — CAMPYLOBACTER CHEK (January 22, 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)
  • K173217 — CAMPYLOBACTER QUIK CHEK (January 22, 2018)
  • K173219 — CAMPYLOBACTER 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)

FDA data resources