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FDA 510(k)

ROTALEX 2 LATEX AGGLUTINATION TEST FOR ROTAVIRUS

K-Number: K854129 · 1986-01-21

ApplicantOrion Diagnostica, Inc.
Decision Date1986-01-21
Product CodeLIQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ROTALEX 2 LATEX AGGLUTINATION TEST FOR ROTAVIRUS 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 1986-01-21 under 510(k) number K854129. 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 ROTALEX 2 LATEX AGGLUTINATION TEST FOR ROTAVIRUS?

ROTALEX 2 LATEX AGGLUTINATION TEST FOR ROTAVIRUS is a medical device that received FDA 510(k) clearance on 1986-01-21. The listed applicant is Orion Diagnostica, Inc.. The 510(k) number is K854129.

When did ROTALEX 2 LATEX AGGLUTINATION TEST FOR ROTAVIRUS receive FDA 510(k) clearance?

ROTALEX 2 LATEX AGGLUTINATION TEST FOR ROTAVIRUS received FDA 510(k) clearance on 1986-01-21, under 510(k) number K854129.

Who is the listed applicant for ROTALEX 2 LATEX AGGLUTINATION TEST FOR ROTAVIRUS?

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 ROTALEX 2 LATEX AGGLUTINATION TEST FOR ROTAVIRUS?

The FDA product code for ROTALEX 2 LATEX AGGLUTINATION TEST FOR ROTAVIRUS is LIQ.

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Other records listing Orion Diagnostica, Inc. as applicant

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.

K942286DIARLEX ROTA-ADENOK914892SALIVA-STIMK904655PYLORISETK884074IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN GK884147IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN MK884075IMMUNOCHEMICAL DETERMINATION OF TRANSFERRIN

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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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