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FDA 510(k)

BIOPLEX VASCULITIS KIT

K-Number: K072358 · 2007-10-31

ApplicantBio-Rad Laboratories
Decision Date2007-10-31
Product CodeMVJ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

BIOPLEX VASCULITIS KIT is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad Laboratories. It received FDA 510(k) clearance on 2007-10-31 under 510(k) number K072358. The device is classified under product code MVJ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOPLEX VASCULITIS KIT?

BIOPLEX VASCULITIS KIT is a medical device that received FDA 510(k) clearance on 2007-10-31. The listed applicant is Bio-Rad Laboratories. The 510(k) number is K072358.

When did BIOPLEX VASCULITIS KIT receive FDA 510(k) clearance?

BIOPLEX VASCULITIS KIT received FDA 510(k) clearance on 2007-10-31, under 510(k) number K072358.

Who is the listed applicant for BIOPLEX VASCULITIS KIT?

The FDA 510(k) record lists Bio-Rad Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOPLEX VASCULITIS KIT?

The FDA product code for BIOPLEX VASCULITIS KIT is MVJ.

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Related Devices (Code: MVJ)

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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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