RAPID IMMUNO-ASSAY SYS— 510(k) K840257

Name: FDA 510(k) clearance K840257
Creator: U.S. Food and Drug Administration
Published: 1984-04-19

Substantially Equivalent

Applied Polytechnology, Inc.

FDA 510(k) clearance K840257 for RAPID IMMUNO-ASSAY SYS, Substantially Equivalent on 1984-04-19. Applicant: Applied Polytechnology, Inc.. Device class: 2.

Clearance details

Applicant: Applied Polytechnology, Inc.
Product code: Code LLG
Device class: Class 2
Regulation: 21 CFR 864.5425
Advisory panel: Hematology
Date received: 1984-01-23
Decision date: 1984-04-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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