510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K130053Substantially Equivalent

Bioplex 2200 Celiac Iga and Igg Kits on the Bioplex 2200 System, Bioplex 2200 Celiac Iga and Igg Calibrator Sets, and Bi

Bio-Rad Laboratories Inc., Benicia CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K130053 is the FDA 510(k) clearance record for BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CELIAC IGA AND IGG CALIBRATOR SETS, AND BI, a class II device, cleared for Bio-Rad Laboratories, Inc. on under FDA product code MVM (Autoantibodies, Endomysial(Tissue Transglutaminase)). FDA records list 128 510(k) clearances for Bio-Rad Laboratories, Inc., from to . As of , FDA records show no recalls naming K130053.

Clearance record

Decision date
Received
(247 days to decision)
Product code
MVM Autoantibodies, Endomysial(Tissue Transglutaminase)
Regulation
21 CFR 866.5660
Device class
Class II
Review panel
Immunology
Applicant
Bio-Rad Laboratories, Inc. 5500 E. 2nd St., Benicia CA
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