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FDA 510(k)

VDRL CARBON ANTIGEN

K-Number: K812894 · 1981-11-06

ApplicantOxoid U.S.A., Inc.
Decision Date1981-11-06
Product CodeGMQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VDRL CARBON ANTIGEN is the device name listed in this FDA 510(k) record. The listed applicant is Oxoid U.S.A., Inc.. It received FDA 510(k) clearance on 1981-11-06 under 510(k) number K812894. The device is classified under product code GMQ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VDRL CARBON ANTIGEN?

VDRL CARBON ANTIGEN is a medical device that received FDA 510(k) clearance on 1981-11-06. The listed applicant is Oxoid U.S.A., Inc.. The 510(k) number is K812894.

When did VDRL CARBON ANTIGEN receive FDA 510(k) clearance?

VDRL CARBON ANTIGEN received FDA 510(k) clearance on 1981-11-06, under 510(k) number K812894.

Who is the listed applicant for VDRL CARBON ANTIGEN?

The FDA 510(k) record lists Oxoid U.S.A., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VDRL CARBON ANTIGEN?

The FDA product code for VDRL CARBON ANTIGEN is GMQ.

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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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