CHROMALEX E. COLI 0157 LATEX TEST SYSTEM, PROD. NO. 800— 510(k) K973457

Name: FDA 510(k) clearance K973457
Creator: U.S. Food and Drug Administration
Published: 1998-01-02

Substantially Equivalent

Shared Systems, Inc.

FDA 510(k) clearance K973457 for CHROMALEX E. COLI 0157 LATEX TEST SYSTEM, PROD. NO. 800, Substantially Equivalent on 1998-01-02. Applicant: Shared Systems, Inc.. Device class: 1.

Clearance details

Applicant: Shared Systems, Inc.
Product code: Code GMZ
Device class: Class 1
Regulation: 21 CFR 866.3255
Advisory panel: Microbiology
Date received: 1997-09-12
Decision date: 1998-01-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Martinez, GA, US

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