FDA 510(k)

SYNTHETIC VDRL ANTIGEN

K-Number: K993633 · 2000-02-23

ApplicantCenters for Disease Control and Prevention

Decision Date2000-02-23

Product CodeGMQ

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

SYNTHETIC VDRL ANTIGEN is the device name listed in this FDA 510(k) record. The listed applicant is Centers for Disease Control and Prevention. It received FDA 510(k) clearance on 2000-02-23 under 510(k) number K993633. 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 SYNTHETIC VDRL ANTIGEN?

SYNTHETIC VDRL ANTIGEN is a medical device that received FDA 510(k) clearance on 2000-02-23. The listed applicant is Centers for Disease Control and Prevention. The 510(k) number is K993633.

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

SYNTHETIC VDRL ANTIGEN received FDA 510(k) clearance on 2000-02-23, under 510(k) number K993633.

Who is the listed applicant for SYNTHETIC VDRL ANTIGEN?

The FDA 510(k) record lists Centers for Disease Control and Prevention as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYNTHETIC VDRL ANTIGEN?

The FDA product code for SYNTHETIC VDRL ANTIGEN is GMQ.

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Other records listing Centers for Disease Control and Prevention as applicant

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Related Devices (Code: GMQ)

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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.