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FDA 510(k)

ENZYGNOST(R) ANTI-CMV/IGM

K-Number: K913693 · 1992-02-27

ApplicantBehring Diagnostics, Inc.
Decision Date1992-02-27
Product CodeLFZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ENZYGNOST(R) ANTI-CMV/IGM is the device name listed in this FDA 510(k) record. The listed applicant is Behring Diagnostics, Inc.. It received FDA 510(k) clearance on 1992-02-27 under 510(k) number K913693. The device is classified under product code LFZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENZYGNOST(R) ANTI-CMV/IGM?

ENZYGNOST(R) ANTI-CMV/IGM is a medical device that received FDA 510(k) clearance on 1992-02-27. The listed applicant is Behring Diagnostics, Inc.. The 510(k) number is K913693.

When did ENZYGNOST(R) ANTI-CMV/IGM receive FDA 510(k) clearance?

ENZYGNOST(R) ANTI-CMV/IGM received FDA 510(k) clearance on 1992-02-27, under 510(k) number K913693.

Who is the listed applicant for ENZYGNOST(R) ANTI-CMV/IGM?

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

What is the FDA product code for ENZYGNOST(R) ANTI-CMV/IGM?

The FDA product code for ENZYGNOST(R) ANTI-CMV/IGM is LFZ.

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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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