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FDA 510(k)

VERIFY(R) REFERENCE PLASMA

K-Number: K881348 · 1988-05-02

ApplicantOrganon Teknika Corp.
Decision Date1988-05-02
Product CodeGGN
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

VERIFY(R) REFERENCE PLASMA is the device name listed in this FDA 510(k) record. The listed applicant is Organon Teknika Corp.. It received FDA 510(k) clearance on 1988-05-02 under 510(k) number K881348. The device is classified under product code GGN. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VERIFY(R) REFERENCE PLASMA?

VERIFY(R) REFERENCE PLASMA is a medical device that received FDA 510(k) clearance on 1988-05-02. The listed applicant is Organon Teknika Corp.. The 510(k) number is K881348.

When did VERIFY(R) REFERENCE PLASMA receive FDA 510(k) clearance?

VERIFY(R) REFERENCE PLASMA received FDA 510(k) clearance on 1988-05-02, under 510(k) number K881348.

Who is the listed applicant for VERIFY(R) REFERENCE PLASMA?

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

What is the FDA product code for VERIFY(R) REFERENCE PLASMA?

The FDA product code for VERIFY(R) REFERENCE PLASMA is GGN.

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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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