Campylobacter Chek— 510(k) K191442

Substantially Equivalent

Techlab, Inc.

FDA 510(k) clearance K191442 for Campylobacter Chek, Substantially Equivalent on 2019-06-20. Applicant: Techlab, Inc.. Device class: 1.

Clearance details

Applicant: Techlab, Inc.
Product code: Code LQP
Device class: Class 1
Regulation: 21 CFR 866.3110
Advisory panel: Microbiology
Date received: 2019-05-30
Decision date: 2019-06-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Blacksburg, VA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LQP

K210976 — Curian Campy2021-12-23
K211342 — Sofia 2 Campylobacter FIA2021-11-23
K191456 — Campylobacter Quik Chek2019-06-20
K173217 — CAMPYLOBACTER QUIK CHEK2018-01-22
K173219 — CAMPYLOBACTER CHEK2018-01-22

More clearances from Techlab, Inc.

K181379 — H. PYLORI QUIK CHEK2018-08-21
K181400 — H. PYLORI CHEK2018-08-21
K171078 — TRI-COMBO PARASITE SCREEN2017-07-10
K170728 — E. HISTOLYTICA QUIK CHEK2017-06-07
K082499 — C. DIFF QUIK CHEK COMPLETE2009-03-26

Data sourced from openFDA. This site is unofficial and independent of the FDA.