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FDA 510(k)

ENZYGNOST TOXOPLASMOSIS/IGM

K-Number: K913505 · 1992-03-04

ApplicantBehring Diagnostics, Inc.
Decision Date1992-03-04
Product CodeLGD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ENZYGNOST TOXOPLASMOSIS/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 1992-03-04 under 510(k) number K913505. The device is classified under product code LGD. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENZYGNOST TOXOPLASMOSIS/IGM?

ENZYGNOST TOXOPLASMOSIS/IGM is a medical device that received FDA 510(k) clearance on 1992-03-04. The listed applicant is Behring Diagnostics, Inc.. The 510(k) number is K913505.

When did ENZYGNOST TOXOPLASMOSIS/IGM receive FDA 510(k) clearance?

ENZYGNOST TOXOPLASMOSIS/IGM received FDA 510(k) clearance on 1992-03-04, under 510(k) number K913505.

Who is the listed applicant for ENZYGNOST TOXOPLASMOSIS/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 TOXOPLASMOSIS/IGM?

The FDA product code for ENZYGNOST TOXOPLASMOSIS/IGM is LGD.

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Other records listing Behring Diagnostics, Inc. as applicant

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Related Devices (Code: LGD)

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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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