The following data is part of a premarket notification filed by Diabetes Technologies, Inc. with the FDA for Accu-base Hemoglobin A1c Sample Collection Kit.
| Device ID | K013465 |
| 510k Number | K013465 |
| Device Name: | ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | DIABETES TECHNOLOGIES, INC. 216 WEST JACKSON ST. Thomasville, GA 31792 |
| Contact | Arthur G Williams |
| Correspondent | Arthur G Williams DIABETES TECHNOLOGIES, INC. 216 WEST JACKSON ST. Thomasville, GA 31792 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-18 |
| Decision Date | 2002-01-22 |