DIRRECT AGGLUTINATION(DAG) PREGNANCY TEST— 510(k) K852286

Name: FDA 510(k) clearance K852286
Creator: U.S. Food and Drug Administration
Published: 1985-07-09

Substantially Equivalent

Sero-Immuno Diagnostics, Inc.

FDA 510(k) clearance K852286 for DIRRECT AGGLUTINATION(DAG) PREGNANCY TEST, Substantially Equivalent on 1985-07-09. Applicant: Sero-Immuno Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Sero-Immuno Diagnostics, Inc.
Product code: Code JHJ
Device class: Class 2
Regulation: 21 CFR 862.1155
Advisory panel: Clinical Chemistry
Date received: 1985-05-29
Decision date: 1985-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tucker, GA, US

Download summary PDF View on FDA.gov ↗

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