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FDA 510(k)

SAS SALMONELLA O GROUP B ANTIGEN

K-Number: K953848 · 1995-10-26

ApplicantSa Scientific, Inc.
Decision Date1995-10-26
Product CodeGNC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SAS SALMONELLA O GROUP B ANTIGEN 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 1995-10-26 under 510(k) number K953848. The device is classified under product code GNC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAS SALMONELLA O GROUP B ANTIGEN?

SAS SALMONELLA O GROUP B ANTIGEN is a medical device that received FDA 510(k) clearance on 1995-10-26. The listed applicant is Sa Scientific, Inc.. The 510(k) number is K953848.

When did SAS SALMONELLA O GROUP B ANTIGEN receive FDA 510(k) clearance?

SAS SALMONELLA O GROUP B ANTIGEN received FDA 510(k) clearance on 1995-10-26, under 510(k) number K953848.

Who is the listed applicant for SAS SALMONELLA O GROUP B ANTIGEN?

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 SALMONELLA O GROUP B ANTIGEN?

The FDA product code for SAS SALMONELLA O GROUP B ANTIGEN is GNC.

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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: GNC)

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.

K972388VISTA ANTIGEN SALMONELLA O GROUP CLee Laboratories, Inc.K972395VISTA ANTIGEN SALMONELLA O GROUP DLee Laboratories, Inc.K972389VISTA ANTIGEN SALMONELLA H DLee Laboratories, Inc.K972387VISTA ANTIGEN SALMONELLA O GROUP ALee Laboratories, Inc.K972386VISTA ANTIGEN SALMONELLA O GROUP BLee Laboratories, Inc.K972391VISTA ANTIGEN SALMONELLA H BLee Laboratories, 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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