I-CHROMA CRP TEST— 510(k) K062981

Substantially Equivalent

Boditech Diagnostics, Inc.

FDA 510(k) clearance K062981 for I-CHROMA CRP TEST, Substantially Equivalent on 2007-07-13. Applicant: Boditech Diagnostics, Inc..

Clearance details

Applicant: Boditech Diagnostics, Inc.
Product code: Code DCN
Advisory panel: Immunology
Date received: 2006-09-29
Decision date: 2007-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Stroudsburg, PA, US

Download summary PDF View on FDA.gov ↗

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