The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Precision Xtra/medisense Optium/precision Easy/medisense Optium Easy Blood Glucose Test Strip With True Measure Technolo.
| Device ID | K023256 |
| 510k Number | K023256 |
| Device Name: | PRECISION XTRA/MEDISENSE OPTIUM/PRECISION EASY/MEDISENSE OPTIUM EASY BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLO |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | ABBOTT LABORATORIES 4-A CROSBY DR. Bedford, MA 01730 -1402 |
| Contact | Janet Connolly |
| Correspondent | Janet Connolly ABBOTT LABORATORIES 4-A CROSBY DR. Bedford, MA 01730 -1402 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-30 |
| Decision Date | 2003-04-23 |
| Summary: | summary |