RAICHEM RHEUMATOID FACTOR SPIA— 510(k) K970373

Name: FDA 510(k) clearance K970373
Creator: U.S. Food and Drug Administration
Published: 1997-04-17

Substantially Equivalent

Henage Diagnostics, Inc.

FDA 510(k) clearance K970373 for RAICHEM RHEUMATOID FACTOR SPIA, Substantially Equivalent on 1997-04-17. Applicant: Henage Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Henage Diagnostics, Inc.
Product code: Code DHR
Device class: Class 2
Regulation: 21 CFR 866.5775
Advisory panel: Immunology
Date received: 1997-02-03
Decision date: 1997-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.