510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K170509Substantially Equivalent

BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set

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

K170509 is the FDA 510(k) clearance record for BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set, a class II device, cleared for Bio-Rad Laboratories on under FDA product code PUQ (Multiplex Flow Immunoassay, T. Gondii, Rubella, Cmv Igm). FDA's definition for product code PUQ reads: "The kit is a multiplex flow immunoassay intended for the qualitative detection of IgM antibodies to Toxoplasma gondii (T. gondii), Rubella, and Cytomegalovirus (CMV) in human serum and plasma". FDA records list 128 510(k) clearances for Bio-Rad Laboratories, from to . As of , FDA records show no recalls naming K170509.

Clearance record

Decision date
Received
(87 days to decision)
Product code
PUQ Multiplex Flow Immunoassay, T. Gondii, Rubella, Cmv Igm
Regulation
21 CFR 866.3510
Device class
Class II
Review panel
Microbiology
Applicant
Bio-Rad Laboratories 5500 E. Second St., Benicia CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PUQ

Trailing 12 months

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

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