The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Medisense Precision Pcx Point Of Care Management System For Blood Glucose Testing.
| Device ID | K022941 |
| 510k Number | K022941 |
| Device Name: | MEDISENSE PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM FOR BLOOD GLUCOSE TESTING |
| Classification | Glucose Dehydrogenase, Glucose |
| Applicant | ABBOTT LABORATORIES 4-A CROSBY DR. Bedford, MA 01730 -1402 |
| Contact | Joseph Magliozzi |
| Correspondent | Joseph Magliozzi ABBOTT LABORATORIES 4-A CROSBY DR. Bedford, MA 01730 -1402 |
| Product Code | LFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-03 |
| Decision Date | 2002-10-28 |
| Summary: | summary |