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FDA 510(k)

ROTA-DAN RAPID ROTAVIRUS EIA KIT

K-Number: K951208 · 1996-02-14

ApplicantEldan Technologies, Ltd.
Decision Date1996-02-14
Product CodeLIQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ROTA-DAN RAPID ROTAVIRUS EIA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Eldan Technologies, Ltd.. It received FDA 510(k) clearance on 1996-02-14 under 510(k) number K951208. 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 ROTA-DAN RAPID ROTAVIRUS EIA KIT?

ROTA-DAN RAPID ROTAVIRUS EIA KIT is a medical device that received FDA 510(k) clearance on 1996-02-14. The listed applicant is Eldan Technologies, Ltd.. The 510(k) number is K951208.

When did ROTA-DAN RAPID ROTAVIRUS EIA KIT receive FDA 510(k) clearance?

ROTA-DAN RAPID ROTAVIRUS EIA KIT received FDA 510(k) clearance on 1996-02-14, under 510(k) number K951208.

Who is the listed applicant for ROTA-DAN RAPID ROTAVIRUS EIA KIT?

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

What is the FDA product code for ROTA-DAN RAPID ROTAVIRUS EIA KIT?

The FDA product code for ROTA-DAN RAPID ROTAVIRUS EIA KIT is LIQ.

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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.K942286DIARLEX ROTA-ADENOOrion Diagnostica, Inc.

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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