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FDA 510(k)

SAS SALMONELLA O FACTOR 4 ANTISERUM &/OR SAS SALMONELLA O GROUP B FACTOR 4,5 ANTISERUM

K-Number: K960125 · 1996-03-06

ApplicantSa Scientific, Inc.
Decision Date1996-03-06
Product CodeGRM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SAS SALMONELLA O FACTOR 4 ANTISERUM &/OR SAS SALMONELLA O GROUP B FACTOR 4,5 ANTISERUM 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 1996-03-06 under 510(k) number K960125. The device is classified under product code GRM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAS SALMONELLA O FACTOR 4 ANTISERUM &/OR SAS SALMONELLA O GROUP B FACTOR 4,5 ANTISERUM?

SAS SALMONELLA O FACTOR 4 ANTISERUM &/OR SAS SALMONELLA O GROUP B FACTOR 4,5 ANTISERUM is a medical device that received FDA 510(k) clearance on 1996-03-06. The listed applicant is Sa Scientific, Inc.. The 510(k) number is K960125.

When did SAS SALMONELLA O FACTOR 4 ANTISERUM &/OR SAS SALMONELLA O GROUP B FACTOR 4,5 ANTISERUM receive FDA 510(k) clearance?

SAS SALMONELLA O FACTOR 4 ANTISERUM &/OR SAS SALMONELLA O GROUP B FACTOR 4,5 ANTISERUM received FDA 510(k) clearance on 1996-03-06, under 510(k) number K960125.

Who is the listed applicant for SAS SALMONELLA O FACTOR 4 ANTISERUM &/OR SAS SALMONELLA O GROUP B FACTOR 4,5 ANTISERUM?

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 FACTOR 4 ANTISERUM &/OR SAS SALMONELLA O GROUP B FACTOR 4,5 ANTISERUM?

The FDA product code for SAS SALMONELLA O FACTOR 4 ANTISERUM &/OR SAS SALMONELLA O GROUP B FACTOR 4,5 ANTISERUM is GRM.

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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: GRM)

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.

K961953SAS SALMONELA H Z24 ANTISERUMSa Scientific, Inc.K961966SAS SALMONELLA O GROUP X FACTOR 47 ANTISERUMSa Scientific, Inc.K961957SAS SALMONELLA H Z4, Z32 ANTISERUMSa Scientific, Inc.K961952SAS SALMONELLA O FACTOR /O GROUP A FACTOR 2 ANTISERUMSSa Scientific, Inc.K961955SAS SALMONELLA H Z42 ANTISERUMSa Scientific, Inc.K961961SAS SALMONELLA H F,G,T ANTISERUMSa 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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