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FDA 510(k)

THE WELLCOME ROTAVIRUS LATEX TEST ZL40

K-Number: K861634 · 1986-10-29

ApplicantWellcome Diagnostics
Decision Date1986-10-29
Product CodeLIQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

THE WELLCOME ROTAVIRUS LATEX TEST ZL40 is the device name listed in this FDA 510(k) record. The listed applicant is Wellcome Diagnostics. It received FDA 510(k) clearance on 1986-10-29 under 510(k) number K861634. 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 THE WELLCOME ROTAVIRUS LATEX TEST ZL40?

THE WELLCOME ROTAVIRUS LATEX TEST ZL40 is a medical device that received FDA 510(k) clearance on 1986-10-29. The listed applicant is Wellcome Diagnostics. The 510(k) number is K861634.

When did THE WELLCOME ROTAVIRUS LATEX TEST ZL40 receive FDA 510(k) clearance?

THE WELLCOME ROTAVIRUS LATEX TEST ZL40 received FDA 510(k) clearance on 1986-10-29, under 510(k) number K861634.

Who is the listed applicant for THE WELLCOME ROTAVIRUS LATEX TEST ZL40?

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

What is the FDA product code for THE WELLCOME ROTAVIRUS LATEX TEST ZL40?

The FDA product code for THE WELLCOME ROTAVIRUS LATEX TEST ZL40 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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