510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K011396Substantially Equivalent

Ibd-Chek

Techlab, Inc., Blacksburg VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011396 is the FDA 510(k) clearance record for IBD-CHEK, a class I device, cleared for Techlab, Inc. on under FDA product code DEG (Lactoferrin, Antigen, Antiserum, Control). FDA records list 36 510(k) clearances for Techlab, Inc., from to . As of , FDA records show no recalls naming K011396.

Clearance record

Decision date
Received
(42 days to decision)
Product code
DEG Lactoferrin, Antigen, Antiserum, Control
Regulation
21 CFR 866.5570
Device class
Class I
Review panel
Immunology
Applicant
Techlab, Inc. 1861 Pratt Dr., Suite 1030, Blacksburg VA
510(k) summary
Summary
Third party review
No

Clearances, product code DEG

Trailing 12 months

FDA records hold no clearances under product code DEG in the trailing twelve months.

FDA records show no clearances under product code DEG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DEG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260