QUANTA Flash HMGCR Reagents— 510(k) K180975

Clearance details

Applicant

Inova Diagnostics, Inc.

Product code

Code LLL

Device class

Class 2

Regulation

21 CFR 866.5100

Advisory panel

Immunology

Date received

2018-04-13

Decision date

2018-06-25

Decision

Substantially Equivalent

Clearance type

Traditional

Location

San Diego, CA, US

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