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FDA 510(k)

ROTALEX

K-Number: K860529 · 1986-03-04

ApplicantOrion Corp.
Decision Date1986-03-04
Product CodeLIQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ROTALEX is the device name listed in this FDA 510(k) record. The listed applicant is Orion Corp.. It received FDA 510(k) clearance on 1986-03-04 under 510(k) number K860529. 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?

ROTALEX is a medical device that received FDA 510(k) clearance on 1986-03-04. The listed applicant is Orion Corp.. The 510(k) number is K860529.

When did ROTALEX receive FDA 510(k) clearance?

ROTALEX received FDA 510(k) clearance on 1986-03-04, under 510(k) number K860529.

Who is the listed applicant for ROTALEX?

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

What is the FDA product code for ROTALEX?

The FDA product code for ROTALEX is LIQ.

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Other records listing Orion Corp. 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.

K912391RUBALEX, MODIFICATIONK901637RESUBMITTED MODIFIED RUBALEXK884650RESUBMITTED SCANORAK890199DENTOCULT SM-STRIP MUTANSK881506MAMEX DC MAG MG12K881505MAMEX DC MG11

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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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