The following data is part of a premarket notification filed by Medisense, Inc. with the FDA for Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose Test Strips, Precision Xtra B-ketone Test St.
| Device ID | K983504 |
| 510k Number | K983504 |
| Device Name: | PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM, PRECISION BLOOD GLUCOSE TEST STRIPS, PRECISION XTRA B-KETONE TEST ST |
| Classification | Glucose Oxidase, Glucose |
| Applicant | MEDISENSE, INC. 4-A CROSBY DR. Bedford, MA 01730 -1402 |
| Contact | Michael Halpin |
| Correspondent | Michael Halpin MEDISENSE, INC. 4-A CROSBY DR. Bedford, MA 01730 -1402 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-06 |
| Decision Date | 1999-07-09 |
| Summary: | summary |