E. HISTOLYTICA QUIK CHEK— 510(k) K170728

Substantially Equivalent

Techlab, Inc.

FDA 510(k) clearance K170728 for E. HISTOLYTICA QUIK CHEK, Substantially Equivalent on 2017-06-07. Applicant: Techlab, Inc.. Device class: 2.

Clearance details

Applicant: Techlab, Inc.
Product code: Code KHW
Device class: Class 2
Regulation: 21 CFR 866.3220
Advisory panel: Microbiology
Date received: 2017-03-09
Decision date: 2017-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Blacksburg, VA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KHW

K994101 — E. HISTOLYTICA II1999-12-21
K955895 — E. HISTOLYTICA TEST1996-08-30
K954996 — TREND AMEBIASIS (E.HISTOLYTICA) SEROLOGICAL ELISA TEST SYSTEM1996-08-08
K944791 — ENTAMOEBA TEST1995-03-09
K900604 — DIRECT FLUORESCENT ANTIBODY REAGENT FOR GIARDIA1990-07-26

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K191442 — Campylobacter Chek2019-06-20
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K181379 — H. PYLORI QUIK CHEK2018-08-21
K181400 — H. PYLORI CHEK2018-08-21
K173217 — CAMPYLOBACTER QUIK CHEK2018-01-22

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