QUANTA LITE M2 EP (MIT3) ELISA— 510(k) K052262

Substantially Equivalent

Inova Diagnostics, Inc.

FDA 510(k) clearance K052262 for QUANTA LITE M2 EP (MIT3) ELISA, Substantially Equivalent on 2005-10-27. Applicant: Inova Diagnostics, Inc..

Clearance details

Applicant: Inova Diagnostics, Inc.
Product code: Code DBM
Advisory panel: Immunology
Date received: 2005-08-19
Decision date: 2005-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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