IMMUNOSCAN DIRECT HEMOPHILUS INFLUENZAE TYPE B TES— 510(k) K854490

Name: FDA 510(k) clearance K854490
Creator: U.S. Food and Drug Administration
Published: 1985-12-27

Substantially Equivalent

American Micro Scan

FDA 510(k) clearance K854490 for IMMUNOSCAN DIRECT HEMOPHILUS INFLUENZAE TYPE B TES, Substantially Equivalent on 1985-12-27. Applicant: American Micro Scan. Device class: 2.

Clearance details

Applicant: American Micro Scan
Product code: Code GRP
Device class: Class 2
Regulation: 21 CFR 866.3300
Advisory panel: Microbiology
Date received: 1985-11-12
Decision date: 1985-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sacramento, CA, US

Download summary PDF View on FDA.gov ↗

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