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FDA 510(k)

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

K-Number: K170509 · 2017-05-19

ApplicantBio-Rad Laboratories
Decision Date2017-05-19
Product CodePUQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set is a medical device manufactured by Bio-Rad Laboratories. It received FDA 510(k) clearance on 2017-05-19 under approval number K170509. The device is classified under product code PUQ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set?

BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set is a medical device that received FDA 510(k) clearance on 2017-05-19. It is manufactured by Bio-Rad Laboratories. The 510(k) number is K170509.

When was BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set approved by the FDA?

BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set received FDA 510(k) clearance on 2017-05-19, under approval number K170509.

What company makes BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set?

BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set is manufactured by Bio-Rad Laboratories.

What is the FDA product code for BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set?

The FDA product code for BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set is PUQ.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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