SAS SHIGELLA DYSENTERIAE GROUP A (1-7) ANTISERUM— 510(k) K953316

Name: FDA 510(k) clearance K953316
Creator: U.S. Food and Drug Administration
Published: 1995-08-04

Substantially Equivalent

Sa Scientific, Inc.

FDA 510(k) clearance K953316 for SAS SHIGELLA DYSENTERIAE GROUP A (1-7) ANTISERUM, Substantially Equivalent on 1995-08-04. 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: 1995-07-13
Decision date: 1995-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, US

Download summary PDF View on FDA.gov ↗

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