The following data is part of a premarket notification filed by Home Access Health Corp. with the FDA for Home Access Aic Test.
| Device ID | K141944 |
| 510k Number | K141944 |
| Device Name: | HOME ACCESS AIC TEST |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | HOME ACCESS HEALTH CORP. 62 FOREST STREET SUITE 300 Marlborough, MA 01752 |
| Contact | Sandra D White |
| Correspondent | Sandra D White ICON Clinical Research LLC 62 FOREST STREET SUITE 300 Marlborough, MA 01752 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-17 |
| Decision Date | 2015-03-13 |
| Summary: | summary |