RAPID DIRECT STREP A LATEX AGGLUTINATION TEST— 510(k) K852841

Substantially Equivalent

Smithkline Diagnostics, Inc.

FDA 510(k) clearance K852841 for RAPID DIRECT STREP A LATEX AGGLUTINATION TEST, Substantially Equivalent on 1985-07-24. Applicant: Smithkline Diagnostics, Inc..

Clearance details

Applicant: Smithkline Diagnostics, Inc.
Product code: Code GTZ
Advisory panel: Microbiology
Date received: 1985-07-05
Decision date: 1985-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

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