UA-Cellular Complete— 510(k) K170091

Substantially Equivalent

Streck

FDA 510(k) clearance K170091 for UA-Cellular Complete, Substantially Equivalent on 2017-02-09. Applicant: Streck. Device class: 1.

Clearance details

Applicant: Streck
Product code: Code JJW
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 2017-01-10
Decision date: 2017-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: La Vista, NE, US

Download summary PDF View on FDA.gov ↗

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