QUANTA LITE H-TTG/DGP SCREEN— 510(k) K070083

Substantially Equivalent

Inova Diagnostics, Inc.

FDA 510(k) clearance K070083 for QUANTA LITE H-TTG/DGP SCREEN, Substantially Equivalent on 2007-03-12. Applicant: Inova Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant
Inova Diagnostics, Inc.
Product code
Code MST
Device class
Class 2
Regulation
21 CFR 866.5750
Advisory panel
Immunology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
San Diego, CA, US
Download summary PDFView on FDA.gov ↗

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