HOLOTC RIA— 510(k) K030655

Substantially Equivalent

Axis-Shield Biochemicals, Asa

FDA 510(k) clearance K030655 for HOLOTC RIA, Substantially Equivalent on 2004-01-29. Applicant: Axis-Shield Biochemicals, Asa.

Clearance details

Applicant: Axis-Shield Biochemicals, Asa
Product code: Code CDD
Advisory panel: Clinical Chemistry
Date received: 2003-03-03
Decision date: 2004-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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