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FDA 510(k)

SAS BRUCELLA ABORTUS ANTIGEN

K-Number: K952147 · 1995-07-17

ApplicantSa Scientific, Inc.
Decision Date1995-07-17
Product CodeGSO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SAS BRUCELLA ABORTUS 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 1995-07-17 under 510(k) number K952147. The device is classified under product code GSO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAS BRUCELLA ABORTUS ANTIGEN?

SAS BRUCELLA ABORTUS ANTIGEN is a medical device that received FDA 510(k) clearance on 1995-07-17. The listed applicant is Sa Scientific, Inc.. The 510(k) number is K952147.

When did SAS BRUCELLA ABORTUS ANTIGEN receive FDA 510(k) clearance?

SAS BRUCELLA ABORTUS ANTIGEN received FDA 510(k) clearance on 1995-07-17, under 510(k) number K952147.

Who is the listed applicant for SAS BRUCELLA ABORTUS 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 BRUCELLA ABORTUS ANTIGEN?

The FDA product code for SAS BRUCELLA ABORTUS ANTIGEN is GSO.

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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: GSO)

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.

K972396VISTA ANTIGEN BRUCELLA MELITENSISLee Laboratories, Inc.K972394VISTA ANTIGEN BRUCELLA ABORTUSLee Laboratories, Inc.K952139SAS BRUCELLA SUIS ANTIGENSa Scientific, Inc.K952140SAS BRUCELLA MELTIENSIS ANTIGENSa Scientific, Inc.K952137SAS SALMONELLA H A ANTIGENSa Scientific, Inc.K952136SAS SALMONELLA H B ANTIGENSa Scientific, 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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