IMMUNOSCAN RAPID DIRECT GROUP A STREP TEST— 510(k) K854447

Substantially Equivalent

American Micro Scan

FDA 510(k) clearance K854447 for IMMUNOSCAN RAPID DIRECT GROUP A STREP TEST, Substantially Equivalent on 1986-01-03. Applicant: American Micro Scan.

Clearance details

Applicant: American Micro Scan
Product code: Code GTZ
Advisory panel: Microbiology
Date received: 1985-11-05
Decision date: 1986-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sacramento, CA, US

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