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FDA 510(k)

ENZYGNOST ROTAVIRUS AG

K-Number: K841243 · 1984-10-17

ApplicantBehring Diagnostics, Inc.
Decision Date1984-10-17
Product CodeLIQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ENZYGNOST ROTAVIRUS AG 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 1984-10-17 under 510(k) number K841243. The device is classified under product code LIQ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENZYGNOST ROTAVIRUS AG?

ENZYGNOST ROTAVIRUS AG is a medical device that received FDA 510(k) clearance on 1984-10-17. The listed applicant is Behring Diagnostics, Inc.. The 510(k) number is K841243.

When did ENZYGNOST ROTAVIRUS AG receive FDA 510(k) clearance?

ENZYGNOST ROTAVIRUS AG received FDA 510(k) clearance on 1984-10-17, under 510(k) number K841243.

Who is the listed applicant for ENZYGNOST ROTAVIRUS AG?

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 ROTAVIRUS AG?

The FDA product code for ENZYGNOST ROTAVIRUS AG is LIQ.

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Other records listing Behring Diagnostics, Inc. as applicant

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Related Devices (Code: LIQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K990842SAS ROTA TESTSa Scientific, Inc.K972895VIDAS ROTAVIRUS (RTV) ASSAYBiomerieux Vitek, Inc.K971585IMMUNOCARD STAT! ROTAVIRUSMeridian Diagnostics, Inc.K964424ROTAVIRUS EIATrinity Biotech, Inc.K965092VIDAS ROTAVIRUS ASSAYBiomerieux Vitek, Inc.K951208ROTA-DAN RAPID ROTAVIRUS EIA KITEldan Technologies, Ltd.

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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