510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K080008Substantially Equivalent

Bioplex 2200 System Torc Igg Kit, Calibrator Set and Control Set

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

K080008 is the FDA 510(k) clearance record for BIOPLEX 2200 SYSTEM TORC IGG KIT, CALIBRATOR SET AND CONTROL SET, a class II device, cleared for Bio-Rad Laboratories, Inc. on under FDA product code OMI (Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv). FDA's definition for product code OMI reads: "The kit is a multiplex immunoassay intended for the quantitative detection of IgG antibodies to Toxoplasma gondii (T. gondii) and Rubella, and qualitative detection of Cytomegalovirus (CMV) IgG in human serum and/ or plasma. Indicated as...". FDA records list 128 510(k) clearances for Bio-Rad Laboratories, Inc., from to . As of , FDA records show no recalls naming K080008.

Clearance record

Decision date
Received
(418 days to decision)
Product code
OMI Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv
Regulation
21 CFR 866.3510
Device class
Class II
Review panel
Microbiology
Applicant
Bio-Rad Laboratories, Inc. 49 Plain St., North Attleboro MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OMI

Trailing 12 months

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

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