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FDA 510(k)

RAPID PLASMA REAGIN CARD TEST

K-Number: K842541 · 1984-07-26

ApplicantClinical Sciences, Inc.
Decision Date1984-07-26
Product CodeGMQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RAPID PLASMA REAGIN CARD TEST is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Sciences, Inc.. It received FDA 510(k) clearance on 1984-07-26 under 510(k) number K842541. 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 RAPID PLASMA REAGIN CARD TEST?

RAPID PLASMA REAGIN CARD TEST is a medical device that received FDA 510(k) clearance on 1984-07-26. The listed applicant is Clinical Sciences, Inc.. The 510(k) number is K842541.

When did RAPID PLASMA REAGIN CARD TEST receive FDA 510(k) clearance?

RAPID PLASMA REAGIN CARD TEST received FDA 510(k) clearance on 1984-07-26, under 510(k) number K842541.

Who is the listed applicant for RAPID PLASMA REAGIN CARD TEST?

The FDA 510(k) record lists Clinical Sciences, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RAPID PLASMA REAGIN CARD TEST?

The FDA product code for RAPID PLASMA REAGIN 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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