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.. Device class: 2.

Clearance details

Applicant: Boditech Diagnostics, Inc.
Product code: Code DCN
Device class: Class 2
Regulation: 21 CFR 866.5270
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 ↗

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