MININEPH HUMAN RHEUMATOID FACTOR KIT— 510(k) K041891

Substantially Equivalent

The Binding Site

FDA 510(k) clearance K041891 for MININEPH HUMAN RHEUMATOID FACTOR KIT, Substantially Equivalent on 2004-11-05. Applicant: The Binding Site. Device class: 2.

Clearance details

Applicant
The Binding Site
Product code
Code DHR
Device class
Class 2
Regulation
21 CFR 866.5775
Advisory panel
Immunology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Santa Monica, CA, US
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