DIAZYME LP(A) ASSAY— 510(k) K082488

Substantially Equivalent

General Atomics

FDA 510(k) clearance K082488 for DIAZYME LP(A) ASSAY, Substantially Equivalent on 2009-01-13. Applicant: General Atomics. Device class: 2.

Clearance details

Applicant: General Atomics
Product code: Code DFC
Device class: Class 2
Regulation: 21 CFR 866.5600
Advisory panel: Immunology
Date received: 2008-08-28
Decision date: 2009-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Poway, 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.