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FDA 510(k)

MDA PROTEIN ASSAY

K-Number: K925617 · 1994-01-27

ApplicantOrganon Teknika Corp.
Decision Date1994-01-27
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

MDA PROTEIN ASSAY 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 1994-01-27 under 510(k) number K925617. The device is classified under product code GGP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MDA PROTEIN ASSAY?

MDA PROTEIN ASSAY is a medical device that received FDA 510(k) clearance on 1994-01-27. The listed applicant is Organon Teknika Corp.. The 510(k) number is K925617.

When did MDA PROTEIN ASSAY receive FDA 510(k) clearance?

MDA PROTEIN ASSAY received FDA 510(k) clearance on 1994-01-27, under 510(k) number K925617.

Who is the listed applicant for MDA PROTEIN ASSAY?

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 MDA PROTEIN ASSAY?

The FDA product code for MDA PROTEIN ASSAY is GGP.

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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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