SALMONELLA O GROUPING ANTISERA SET— 510(k) K912791

Name: FDA 510(k) clearance K912791
Creator: U.S. Food and Drug Administration
Published: 1992-10-05

Substantially Equivalent

S.M.I. Medical, Inc.

FDA 510(k) clearance K912791 for SALMONELLA O GROUPING ANTISERA SET, Substantially Equivalent on 1992-10-05. Applicant: S.M.I. Medical, Inc.. Device class: 2.

Clearance details

Applicant: S.M.I. Medical, Inc.
Product code: Code GRM
Device class: Class 2
Regulation: 21 CFR 866.3550
Advisory panel: Microbiology
Date received: 1991-06-25
Decision date: 1992-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Avon, MA, US

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K961949 — SAS SALMONELLA O FACTOR 14 ANTISERUM1996-06-18
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K961951 — SAS SALMONELLA O FACTOR 6 ANTISERUM1996-06-18
K961952 — SAS SALMONELLA O FACTOR /O GROUP A FACTOR 2 ANTISERUMS1996-06-18

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