IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAE— 510(k) K870029

Name: FDA 510(k) clearance K870029
Creator: U.S. Food and Drug Administration
Published: 1987-03-25

Substantially Equivalent

American Micro Scan

FDA 510(k) clearance K870029 for IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAE, Substantially Equivalent on 1987-03-25. Applicant: American Micro Scan. Device class: 1.

Clearance details

Applicant: American Micro Scan
Product code: Code GWC
Device class: Class 1
Regulation: 21 CFR 866.3740
Advisory panel: Microbiology
Date received: 1987-01-05
Decision date: 1987-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Sacramento, CA, US

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