HOME ACCESS AIC TEST— 510(k) K141944

Substantially Equivalent

Home Access Health Corp.

FDA 510(k) clearance K141944 for HOME ACCESS AIC TEST, Substantially Equivalent on 2015-03-13. Applicant: Home Access Health Corp.. Device class: 2.

Clearance details

Applicant: Home Access Health Corp.
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 2014-07-17
Decision date: 2015-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marlborough, MA, 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.