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FDA 510(k)

DADE RPR CARD TEST

K-Number: K811152 · 1981-05-15

ApplicantAmerican Dade
Decision Date1981-05-15
Product CodeGMQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

DADE RPR CARD TEST is the device name listed in this FDA 510(k) record. The listed applicant is American Dade. It received FDA 510(k) clearance on 1981-05-15 under 510(k) number K811152. 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 DADE RPR CARD TEST?

DADE RPR CARD TEST is a medical device that received FDA 510(k) clearance on 1981-05-15. The listed applicant is American Dade. The 510(k) number is K811152.

When did DADE RPR CARD TEST receive FDA 510(k) clearance?

DADE RPR CARD TEST received FDA 510(k) clearance on 1981-05-15, under 510(k) number K811152.

Who is the listed applicant for DADE RPR CARD TEST?

The FDA 510(k) record lists American Dade as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DADE RPR CARD TEST?

The FDA product code for DADE RPR CARD TEST 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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