IBD-CHEK— 510(k) K011396

Substantially Equivalent

Techlab, Inc.

FDA 510(k) clearance K011396 for IBD-CHEK, Substantially Equivalent on 2001-06-18. Applicant: Techlab, Inc.. Device class: 1.

Clearance details

Applicant: Techlab, Inc.
Product code: Code DEG
Device class: Class 1
Regulation: 21 CFR 866.5570
Advisory panel: Immunology
Date received: 2001-05-07
Decision date: 2001-06-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Blacksburg, VA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DEG

K071712 — LEUKO EZ VUE2007-12-04
K042071 — IBD-SCAN2004-10-20
K030704 — IBD-QUIK CHEK2003-04-21
K951101 — LEUKO-TEST1995-04-24
K934473 — LACTOFERRIN MICROASSAY SYSTEM1993-12-03

More clearances from Techlab, Inc.

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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.