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FDA 510(k)

DIARLEX ROTA-ADENO

K-Number: K942286 · 1994-12-14

ApplicantOrion Diagnostica, Inc.
Decision Date1994-12-14
Product CodeLIQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

DIARLEX ROTA-ADENO is the device name listed in this FDA 510(k) record. The listed applicant is Orion Diagnostica, Inc.. It received FDA 510(k) clearance on 1994-12-14 under 510(k) number K942286. 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 DIARLEX ROTA-ADENO?

DIARLEX ROTA-ADENO is a medical device that received FDA 510(k) clearance on 1994-12-14. The listed applicant is Orion Diagnostica, Inc.. The 510(k) number is K942286.

When did DIARLEX ROTA-ADENO receive FDA 510(k) clearance?

DIARLEX ROTA-ADENO received FDA 510(k) clearance on 1994-12-14, under 510(k) number K942286.

Who is the listed applicant for DIARLEX ROTA-ADENO?

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

What is the FDA product code for DIARLEX ROTA-ADENO?

The FDA product code for DIARLEX ROTA-ADENO is LIQ.

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Related Devices (Code: LIQ)

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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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