Aina HbA1c Monitoring System 2— 510(k) K192987

Substantially Equivalent

Jana Care, Inc.

FDA 510(k) clearance K192987 for Aina HbA1c Monitoring System 2, Substantially Equivalent on 2020-03-26. Applicant: Jana Care, Inc.. Device class: 2.

Clearance details

Applicant
Jana Care, Inc.
Product code
Code LCP
Device class
Class 2
Regulation
21 CFR 864.7470
Advisory panel
Hematology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Boston, MA, US
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