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 |