AMTEC RHEUMATOID FACTOR LATEX AGGLUTINATION KIT— 510(k) K873064

Name: FDA 510(k) clearance K873064
Creator: U.S. Food and Drug Administration
Published: 1987-11-04

Substantially Equivalent

Amtec Diagnostics International, Inc.

FDA 510(k) clearance K873064 for AMTEC RHEUMATOID FACTOR LATEX AGGLUTINATION KIT, Substantially Equivalent on 1987-11-04. Applicant: Amtec Diagnostics International, Inc.. Device class: 2.

Clearance details

Applicant: Amtec Diagnostics International, Inc.
Product code: Code DHR
Device class: Class 2
Regulation: 21 CFR 866.5775
Advisory panel: Immunology
Date received: 1987-08-05
Decision date: 1987-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Conroe, TX, US

Download summary PDF View on FDA.gov ↗

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