Diazyme PLAC® Test for Lp-PLA2 Activity— 510(k) K203136

Substantially Equivalent

Diazyme Laboratories, Inc.

FDA 510(k) clearance K203136 for Diazyme PLAC® Test for Lp-PLA2 Activity, Substantially Equivalent on 2021-08-06. Applicant: Diazyme Laboratories, Inc..

Clearance details

Applicant: Diazyme Laboratories, Inc.
Product code: Code NOE
Advisory panel: Immunology
Date received: 2020-10-20
Decision date: 2021-08-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Poway, CA, US

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