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FDA 510(k)

SAS ROTA TEST

K-Number: K990842 · 1999-08-09

ApplicantSa Scientific, Inc.
Decision Date1999-08-09
Product CodeLIQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SAS ROTA TEST is the device name listed in this FDA 510(k) record. The listed applicant is Sa Scientific, Inc.. It received FDA 510(k) clearance on 1999-08-09 under 510(k) number K990842. 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 SAS ROTA TEST?

SAS ROTA TEST is a medical device that received FDA 510(k) clearance on 1999-08-09. The listed applicant is Sa Scientific, Inc.. The 510(k) number is K990842.

When did SAS ROTA TEST receive FDA 510(k) clearance?

SAS ROTA TEST received FDA 510(k) clearance on 1999-08-09, under 510(k) number K990842.

Who is the listed applicant for SAS ROTA TEST?

The FDA 510(k) record lists Sa Scientific, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAS ROTA TEST?

The FDA product code for SAS ROTA TEST is LIQ.

Other records listing Sa Scientific, Inc. 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.

K100227SAS FLUALERT A&B, SAS INFLUENZA A TESTK080380SAS INFLUENZA A & B TESTK041441SAS INFLUENZA A TESTK041439SAS INFLUENZA B TESTK030628SAS RSV CONTROL KITK022845SAS RSV TEST

View all 199 devices →

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.

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.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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