510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K071692Substantially Equivalent

Theratest El-Ttg Iga/igg and Theratest El-Glia Iga/igg Test Systems

Theratest Laboratories, Inc., Lombard IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K071692 is the FDA 510(k) clearance record for THERATEST EL-TTG IGA/IGG AND THERATEST EL-GLIA IGA/IGG TEST SYSTEMS, a class II device, cleared for Theratest Laboratories, Inc. on under FDA product code MVM (Autoantibodies, Endomysial(Tissue Transglutaminase)). FDA records list 23 510(k) clearances for Theratest Laboratories, Inc., from to . As of , FDA records show no recalls naming K071692.

Clearance record

Decision date
Received
(138 days to decision)
Product code
MVM Autoantibodies, Endomysial(Tissue Transglutaminase)
Regulation
21 CFR 866.5660
Device class
Class II
Review panel
Immunology
Applicant
Theratest Laboratories, Inc. 1111 N. Main St., Lombard IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MVM

Trailing 12 months

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

FDA records show no clearances under product code MVM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MVM, 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