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FDA 510(k)

RESUBMITTED ABBOTT TESTPACK ROTAVIRUS

K-Number: K880821 · 1988-05-06

ApplicantAbbott Laboratories
Decision Date1988-05-06
Product CodeLIQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RESUBMITTED ABBOTT TESTPACK ROTAVIRUS is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1988-05-06 under 510(k) number K880821. 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 RESUBMITTED ABBOTT TESTPACK ROTAVIRUS?

RESUBMITTED ABBOTT TESTPACK ROTAVIRUS is a medical device that received FDA 510(k) clearance on 1988-05-06. The listed applicant is Abbott Laboratories. The 510(k) number is K880821.

When did RESUBMITTED ABBOTT TESTPACK ROTAVIRUS receive FDA 510(k) clearance?

RESUBMITTED ABBOTT TESTPACK ROTAVIRUS received FDA 510(k) clearance on 1988-05-06, under 510(k) number K880821.

Who is the listed applicant for RESUBMITTED ABBOTT TESTPACK ROTAVIRUS?

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

What is the FDA product code for RESUBMITTED ABBOTT TESTPACK ROTAVIRUS?

The FDA product code for RESUBMITTED ABBOTT TESTPACK ROTAVIRUS 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.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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