SAS SHIGELLA DYSENTERIAE TYPE 8 ANTISERUM— 510(k) K961538

Name: FDA 510(k) clearance K961538
Creator: U.S. Food and Drug Administration
Published: 1996-05-20

Substantially Equivalent

Sa Scientific, Inc.

FDA 510(k) clearance K961538 for SAS SHIGELLA DYSENTERIAE TYPE 8 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 ↗

Recent devices under product code GNB

view all

K961537 — SAS SHIGELLA SONNEI FORM II ANTISERUM1996-05-31
K961528 — SAS SHIGELLA BOYDII TYPE 11 ANTISERUM (3/100/1000ML)1996-05-20
K961529 — SAS SHIGELLA BOYDII TYPE 12 ANTISERUM1996-05-20
K961531 — SAS SHIGELLA BOYDII TYPE 13 ANTISERUM1996-05-20
K961532 — SAS SHIGELLA FLEXNERI TYPE 5 ANTISERUM1996-05-20

More clearances from Sa Scientific, Inc.

view all

K100227 — SAS FLUALERT A&B, SAS INFLUENZA A TEST2010-02-23
K080380 — SAS INFLUENZA A & B TEST2009-07-23
K041439 — SAS INFLUENZA B TEST2004-07-22
K041441 — SAS INFLUENZA A TEST2004-07-22
K030628 — SAS RSV CONTROL KIT2003-03-17

Data sourced from openFDA. This site is unofficial and independent of the FDA.