Cleared Traditional

SAS SALMONELLA O FACTOR 6 ANTISERUM

K961951 · Sa Scientific, Inc. · Microbiology
Jun 1996
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K961951 is an FDA 510(k) clearance for the SAS SALMONELLA O FACTOR 6 ANTISERUM, a Antisera, All Groups, Salmonella Spp. (Class II — Special Controls, product code GRM), submitted by Sa Scientific, Inc. (San Antonio, US). The FDA issued a Cleared decision on June 18, 1996, 29 days after receiving the submission on May 20, 1996. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3550.

Submission Details

510(k) Number K961951 FDA.gov
FDA Decision Cleared SESE
Date Received May 20, 1996
Decision Date June 18, 1996
Days to Decision 29 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code GRM — Antisera, All Groups, Salmonella Spp.
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3550

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