K163525

Substantially Equivalent

QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) Controls

Applicant: Inova Diagnostics, Inc.
Product code: DBM
Advisory panel: Immunology
Date received: 2016-12-15
Decision date: 2017-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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