K152875

Substantially Equivalent

QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1, HemosIL AcuStar Anti-B2GPI Domain 1 Controls

Applicant: Inova Diagnostics, Inc.
Product code: MSV
Advisory panel: Immunology
Date received: 2015-09-30
Decision date: 2015-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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