QUANTA FLASH RO60, QUANTA FLASH RO60 CALIBRATORS, QUANTA FLASH RO60 CONTROLS— 510(k) K141328

Substantially Equivalent

Inova Diagnostics, Inc.

FDA 510(k) clearance K141328 for QUANTA FLASH RO60, QUANTA FLASH RO60 CALIBRATORS, QUANTA FLASH RO60 CONTROLS, Substantially Equivalent on 2015-02-12. Applicant: Inova Diagnostics, Inc..

Clearance details

Applicant: Inova Diagnostics, Inc.
Product code: Code LLL
Advisory panel: Immunology
Date received: 2014-05-21
Decision date: 2015-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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