DUET HS-CRP LIT ASSAY, CATALOG NUMBER: 4010, DUET HS-CRP CALIBRATOR SET, CATALOG NUMBER: 4511— 510(k) K050713

Substantially Equivalent

Good Biotech Corp.

FDA 510(k) clearance K050713 for DUET HS-CRP LIT ASSAY, CATALOG NUMBER: 4010, DUET HS-CRP CALIBRATOR SET, CATALOG NUMBER: 4511, Substantially Equivalent on 2005-06-06. Applicant: Good Biotech Corp..

Clearance details

Applicant: Good Biotech Corp.
Product code: Code DCN
Advisory panel: Immunology
Date received: 2005-03-18
Decision date: 2005-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taichung, TW

Download summary PDF View on FDA.gov ↗

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