WELLCOLEX COLOUR SALMONELLA TEST ZL 50— 510(k) K890146

Name: FDA 510(k) clearance K890146
Creator: U.S. Food and Drug Administration
Published: 1989-02-16

Substantially Equivalent

Wellcome Diagnostics

FDA 510(k) clearance K890146 for WELLCOLEX COLOUR SALMONELLA TEST ZL 50, Substantially Equivalent on 1989-02-16. Applicant: Wellcome Diagnostics. Device class: 2.

Clearance details

Applicant: Wellcome Diagnostics
Product code: Code GRM
Device class: Class 2
Regulation: 21 CFR 866.3550
Advisory panel: Microbiology
Date received: 1989-01-13
Decision date: 1989-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Research Triangle Pk, NC, US

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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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