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FDA 510(k)

SAS SHIGELLA DYSENTERIAE TYPE 1 ANTISERUM

K-Number: K961553 · 1996-05-20

ApplicantSa Scientific, Inc.
Decision Date1996-05-20
Product CodeGNB
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SAS SHIGELLA DYSENTERIAE TYPE 1 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 1996-05-20 under 510(k) number K961553. The device is classified under product code GNB. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAS SHIGELLA DYSENTERIAE TYPE 1 ANTISERUM?

SAS SHIGELLA DYSENTERIAE TYPE 1 ANTISERUM is a medical device that received FDA 510(k) clearance on 1996-05-20. The listed applicant is Sa Scientific, Inc.. The 510(k) number is K961553.

When did SAS SHIGELLA DYSENTERIAE TYPE 1 ANTISERUM receive FDA 510(k) clearance?

SAS SHIGELLA DYSENTERIAE TYPE 1 ANTISERUM received FDA 510(k) clearance on 1996-05-20, under 510(k) number K961553.

Who is the listed applicant for SAS SHIGELLA DYSENTERIAE TYPE 1 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 SHIGELLA DYSENTERIAE TYPE 1 ANTISERUM?

The FDA product code for SAS SHIGELLA DYSENTERIAE TYPE 1 ANTISERUM is GNB.

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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: GNB)

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.

K961537SAS SHIGELLA SONNEI FORM II ANTISERUMSa Scientific, Inc.K961549SAS SHIGELLA FLEXNERI TYPE 2 ANTISERUMSa Scientific, Inc.K961534SAS SHIGELLA SONNEI FORM I ANTISERUM (3/100/1000ML)Sa Scientific, Inc.K961551SAS SHIGELLA DYSENTERIAE TYPE 2 ANTISERUMSa Scientific, Inc.K961535SAS SHIGELLA DYSENTERIAE GROUP A1 (8-10) ANTISERUMSa Scientific, Inc.K961540SAS SHIGELLA SONNEI GROUP D 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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