AUTION CHECK PLUS— 510(k) K142262

Substantially Equivalent

Quantimetrix Corp.

FDA 510(k) clearance K142262 for AUTION CHECK PLUS, Substantially Equivalent on 2015-04-10. Applicant: Quantimetrix Corp.. Device class: 1.

Clearance details

Applicant: Quantimetrix Corp.
Product code: Code JJW
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 2014-08-14
Decision date: 2015-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redondo Beach, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.