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FDA 510(k)

BIOPLEX 2200 EBV IGG AND SYPHILIS IGG

K-Number: K120439 · 2012-03-14

ApplicantBio-Rad Laboratories, Inc.
Decision Date2012-03-14
Product CodeLIP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BIOPLEX 2200 EBV IGG AND SYPHILIS IGG is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad Laboratories, Inc.. It received FDA 510(k) clearance on 2012-03-14 under 510(k) number K120439. The device is classified under product code LIP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOPLEX 2200 EBV IGG AND SYPHILIS IGG?

BIOPLEX 2200 EBV IGG AND SYPHILIS IGG is a medical device that received FDA 510(k) clearance on 2012-03-14. The listed applicant is Bio-Rad Laboratories, Inc.. The 510(k) number is K120439.

When did BIOPLEX 2200 EBV IGG AND SYPHILIS IGG receive FDA 510(k) clearance?

BIOPLEX 2200 EBV IGG AND SYPHILIS IGG received FDA 510(k) clearance on 2012-03-14, under 510(k) number K120439.

Who is the listed applicant for BIOPLEX 2200 EBV IGG AND SYPHILIS IGG?

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

What is the FDA product code for BIOPLEX 2200 EBV IGG AND SYPHILIS IGG?

The FDA product code for BIOPLEX 2200 EBV IGG AND SYPHILIS IGG is LIP.

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Related Devices (Code: LIP)

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Official Source

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

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