The following data is part of a premarket notification filed by Medisense, Inc. with the FDA for Precision Pcx Point Of Care Management System , Qc Manager Data Manager System, Precision G Plus Blood Glucose Test St.
| Device ID | K982303 |
| 510k Number | K982303 |
| Device Name: | PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM , QC MANAGER DATA MANAGER SYSTEM, PRECISION G PLUS BLOOD GLUCOSE 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 | 1998-07-01 |
| Decision Date | 1998-12-08 |
| Summary: | summary |