The following data is part of a premarket notification filed by Medisense, Inc. with the FDA for Precision A1c Home Hba1c Sample Collection Kit.
| Device ID | K983253 |
| 510k Number | K983253 |
| Device Name: | PRECISION A1C HOME HBA1C SAMPLE COLLECTION KIT |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | MEDISENSE, INC. 4-A CROSBY DR. Bedford, MA 01730 -1402 |
| Contact | Denise Haley |
| Correspondent | Denise Haley MEDISENSE, INC. 4-A CROSBY DR. Bedford, MA 01730 -1402 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-16 |
| Decision Date | 1998-11-20 |
| Summary: | summary |