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510(k) K210976

Curian Campy by Meridian Bioscience, Inc. — Product Code LQP

K210976 is an FDA 510(k) premarket notification submitted by Meridian Bioscience, Inc. for the device "Curian Campy". The FDA issued a decision of Substantially Equivalent on December 23, 2021. The device falls under product code LQP (Campylobacter Spp.), a Class I device regulated under 21 CFR 866.3110. Meridian Bioscience, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2021
Date Received
April 1, 2021
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 Meridian Bioscience, Inc.

  • K243922 — Revogene (March 20, 2025)
  • K230901 — Premier HpSA Flex (619096) (July 3, 2023)
  • K222829 — Curian® Shiga Toxin (April 17, 2023)
  • K222779 — Revogene (January 26, 2023)
  • K220480 — Revogene (July 11, 2022)
  • K192817 — Curian HpSA, Curian Analyzer (March 13, 2020)
  • DEN180040 — Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit (November 30, 2018)
  • K182559 — PREMIER Platinum HpSA PLUS (November 5, 2018)
  • K163273 — TRU Legionella (February 21, 2017)
  • K160829 — illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Dire (June 13, 2016)

Other clearances for product code LQP

  • K211342 — Sofia 2 Campylobacter FIA (November 23, 2021)
  • K191442 — Campylobacter Chek (June 20, 2019)
  • 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