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FDA 510(k)

ABBOTT TESTPACK RSV

K-Number: K874127 · 1988-05-06

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

Device Summary

ABBOTT TESTPACK RSV 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 K874127. The device is classified under product code GQG. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABBOTT TESTPACK RSV?

ABBOTT TESTPACK RSV 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 K874127.

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

ABBOTT TESTPACK RSV received FDA 510(k) clearance on 1988-05-06, under 510(k) number K874127.

Who is the listed applicant for ABBOTT TESTPACK RSV?

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 ABBOTT TESTPACK RSV?

The FDA product code for ABBOTT TESTPACK RSV is GQG.

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Other records listing Abbott Laboratories as applicant

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Related Devices (Code: GQG)

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.

K253318Clungene RSV Antigen Rapid TestHangzhou Clongene Biotech Co., Ltd.K240280Nano-Check™ RSV TestNano-Ditech CorporationK162911Sofia RSV FIA on Sofia 2 analyzerQuidel CorporationK133140BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSVBecton, Dickinson & COK132456BD VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSVBecton, Dickinson and CompanyK130398SOFIA(R) RSV FIAQuidel Corp.

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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