The following data is part of a premarket notification filed by Drawbridge Health, Inc. with the FDA for Onedraw A1c Test System.
| Device ID | K183230 |
| 510k Number | K183230 |
| Device Name: | OneDraw A1C Test System |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | Drawbridge Health, Inc. 11535 Sorrrento Valley Road, Suite 407 San Diego, CA 92121 |
| Contact | Annie Wright |
| Correspondent | Annie Wright Drawbridge Health, Inc. 11535 Sorrrento Valley Road, Suite 407 San Diego, CA 92121 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-20 |
| Decision Date | 2019-08-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00086303000046 | K183230 | 000 |