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FDA 510(k)

VIROGEN ROTATEST SLIDE TEST

K-Number: K853399 · 1985-11-12

ApplicantArmkel, LLC
Decision Date1985-11-12
Product CodeLIQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VIROGEN ROTATEST SLIDE TEST is the device name listed in this FDA 510(k) record. The listed applicant is Armkel, LLC. It received FDA 510(k) clearance on 1985-11-12 under 510(k) number K853399. 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 VIROGEN ROTATEST SLIDE TEST?

VIROGEN ROTATEST SLIDE TEST is a medical device that received FDA 510(k) clearance on 1985-11-12. The listed applicant is Armkel, LLC. The 510(k) number is K853399.

When did VIROGEN ROTATEST SLIDE TEST receive FDA 510(k) clearance?

VIROGEN ROTATEST SLIDE TEST received FDA 510(k) clearance on 1985-11-12, under 510(k) number K853399.

Who is the listed applicant for VIROGEN ROTATEST SLIDE TEST?

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

What is the FDA product code for VIROGEN ROTATEST SLIDE TEST?

The FDA product code for VIROGEN ROTATEST SLIDE TEST is LIQ.

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Other records listing Armkel, LLC 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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