Cleared Traditional

Aina HbA1c Monitoring System 2

K192987 · Jana Care, Inc. · Chemistry

Mar 2020

Decision

153d

Days

Class 2

Risk

About This 510(k) Submission

K192987 is an FDA 510(k) clearance for the Aina HbA1c Monitoring System 2, a Assay, Glycosylated Hemoglobin (Class II — Special Controls, product code LCP), submitted by Jana Care, Inc. (Boston, US). The FDA issued a Cleared decision on March 26, 2020, 153 days after receiving the submission on October 25, 2019. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.7470.

Submission Details

510(k) Number	K192987 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 25, 2019
Decision Date	March 26, 2020
Days to Decision	153 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF