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FDA 510(k)

ENZYGNOST + ANTI-CMV IGG TEST

K-Number: K852478 · 1985-09-16

ApplicantBehring Diagnostics, Inc.
Decision Date1985-09-16
Product CodeLFZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ENZYGNOST + ANTI-CMV IGG TEST 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 1985-09-16 under 510(k) number K852478. 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 + ANTI-CMV IGG TEST?

ENZYGNOST + ANTI-CMV IGG TEST is a medical device that received FDA 510(k) clearance on 1985-09-16. The listed applicant is Behring Diagnostics, Inc.. The 510(k) number is K852478.

When did ENZYGNOST + ANTI-CMV IGG TEST receive FDA 510(k) clearance?

ENZYGNOST + ANTI-CMV IGG TEST received FDA 510(k) clearance on 1985-09-16, under 510(k) number K852478.

Who is the listed applicant for ENZYGNOST + ANTI-CMV IGG TEST?

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 + ANTI-CMV IGG TEST?

The FDA product code for ENZYGNOST + ANTI-CMV IGG TEST is LFZ.

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Related Devices (Code: 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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