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FDA 510(k)

SAS RSV TEST

K-Number: K022845 · 2003-01-29

ApplicantSa Scientific, Inc.
Decision Date2003-01-29
Product CodeGQG
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SAS RSV 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 2003-01-29 under 510(k) number K022845. 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 SAS RSV TEST?

SAS RSV TEST is a medical device that received FDA 510(k) clearance on 2003-01-29. The listed applicant is Sa Scientific, Inc.. The 510(k) number is K022845.

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

SAS RSV TEST received FDA 510(k) clearance on 2003-01-29, under 510(k) number K022845.

Who is the listed applicant for SAS RSV 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 RSV TEST?

The FDA product code for SAS RSV TEST is GQG.

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 KITK022683SAS BLOOD/SERUM/URINE/URINE HCG

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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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