TRIAGE PROTEIN C TEST— 510(k) K062530

Substantially Equivalent

Biosite Incorporated

FDA 510(k) clearance K062530 for TRIAGE PROTEIN C TEST, Substantially Equivalent on 2007-01-29. Applicant: Biosite Incorporated. Device class: 2.

Clearance details

Applicant: Biosite Incorporated
Product code: Code GGP
Device class: Class 2
Regulation: 21 CFR 864.7290
Advisory panel: Hematology
Date received: 2006-08-29
Decision date: 2007-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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