The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Precision Xtra Blood Glucose Test Strip With Truemeasure Technology.
| Device ID | K010553 |
| 510k Number | K010553 |
| Device Name: | PRECISION XTRA BLOOD GLUCOSE TEST STRIP WITH TRUEMEASURE TECHNOLOGY |
| 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 | 2001-02-26 |
| Decision Date | 2001-06-18 |