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FDA 510(k)

SAS(TM) QC ANTIGENS FOR SALMONELLA ANTISERA

K-Number: K945839 · 1995-03-07

ApplicantSa Scientific, Inc.
Decision Date1995-03-07
Product CodeGRL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SAS(TM) QC ANTIGENS FOR SALMONELLA ANTISERA 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 1995-03-07 under 510(k) number K945839. The device is classified under product code GRL. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAS(TM) QC ANTIGENS FOR SALMONELLA ANTISERA?

SAS(TM) QC ANTIGENS FOR SALMONELLA ANTISERA is a medical device that received FDA 510(k) clearance on 1995-03-07. The listed applicant is Sa Scientific, Inc.. The 510(k) number is K945839.

When did SAS(TM) QC ANTIGENS FOR SALMONELLA ANTISERA receive FDA 510(k) clearance?

SAS(TM) QC ANTIGENS FOR SALMONELLA ANTISERA received FDA 510(k) clearance on 1995-03-07, under 510(k) number K945839.

Who is the listed applicant for SAS(TM) QC ANTIGENS FOR SALMONELLA ANTISERA?

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(TM) QC ANTIGENS FOR SALMONELLA ANTISERA?

The FDA product code for SAS(TM) QC ANTIGENS FOR SALMONELLA ANTISERA is GRL.

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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 TESTK041439SAS INFLUENZA B TESTK041441SAS INFLUENZA A TESTK030628SAS RSV CONTROL KITK022845SAS RSV TEST

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Related Devices (Code: GRL)

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.

K820996SALMONELLA & SHIGELLA GROUPING SERAFisher Scientific Co., LLC

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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