RHEUMA-CHECK ENZYME IMMUNOASSAY TEST— 510(k) K871196

Name: FDA 510(k) clearance K871196
Creator: U.S. Food and Drug Administration
Published: 1987-05-06

Substantially Equivalent

Orion Diagnostica, Inc.

FDA 510(k) clearance K871196 for RHEUMA-CHECK ENZYME IMMUNOASSAY TEST, Substantially Equivalent on 1987-05-06. Applicant: Orion Diagnostica, Inc.. Device class: 2.

Clearance details

Applicant: Orion Diagnostica, Inc.
Product code: Code DHR
Device class: Class 2
Regulation: 21 CFR 866.5775
Advisory panel: Immunology
Date received: 1987-03-24
Decision date: 1987-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerset, NJ, US

Download summary PDF View on FDA.gov ↗

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