The following data is part of a premarket notification filed by Jana Care, Inc with the FDA for Aina Hba1c Monitoring System 2.
| Device ID | K192987 |
| 510k Number | K192987 |
| Device Name: | Aina HbA1c Monitoring System 2 |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | Jana Care, Inc 8 Saint Mary's St, Suite 936 Boston, MA 02215 |
| Contact | Michal Depa |
| Correspondent | Fran White MDC Associates, Inc. 180 Cabot St Beverly, MA 01915 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-25 |
| Decision Date | 2020-03-26 |