SAS SHIGELLA DYSENTERIAE GROUP A1 (8-10) ANTISERUM— 510(k) K961535

Name: FDA 510(k) clearance K961535
Creator: U.S. Food and Drug Administration
Published: 1996-05-20

Substantially Equivalent

Sa Scientific, Inc.

FDA 510(k) clearance K961535 for SAS SHIGELLA DYSENTERIAE GROUP A1 (8-10) ANTISERUM, Substantially Equivalent on 1996-05-20. Applicant: Sa Scientific, Inc.. Device class: 2.

Clearance details

Applicant: Sa Scientific, Inc.
Product code: Code GNB
Device class: Class 2
Regulation: 21 CFR 866.3660
Advisory panel: Microbiology
Date received: 1996-04-22
Decision date: 1996-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, US

Download summary PDF View on FDA.gov ↗

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K961531 — SAS SHIGELLA BOYDII TYPE 13 ANTISERUM1996-05-20
K961532 — SAS SHIGELLA FLEXNERI TYPE 5 ANTISERUM1996-05-20

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