FDA Product Code
FDA Product Code NBW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1345
510(k) Clearances — 511 records · page 6 of 6
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K012014 | MODIFICATION TO BLOOD GLUCOSE MONITORING SYSTEM | Abbott Diabetes Care, Inc. | 2001-12-05 | Traditional | PDF ↗ |
| K012324 | ACCU-CHEK ACTIVE TEST SYSTEM | Roche Diagnostics Corp. | 2001-12-05 | Traditional | PDF ↗ |
| K013203 | BIOSCANNER BEYOND GLUCOSE ANALYZER AND TEST STRIPS | Polymer Technology Systems, Inc. | 2001-11-16 | Traditional | PDF ↗ |
| K011240 | EVENCARE BLOOD GLUCOSE MONITORING SYSTEM | Medline Industries, Inc. | 2001-09-13 | Traditional | PDF ↗ |
| K012205 | GLUCOMETER DEX TEST SENSOR | Bayer Corp. | 2001-09-12 | Traditional | PDF ↗ |
| K010039 | QUICKTEK BLOOD GLUCOSE SYSTEM, QUICKTEK BLOOD GLUCOSE METER, QUICKTEK BLOOD GLUCOSE STRIPS, QUICKTEK CONTROL SOLUTION | Chronimed, Inc. | 2001-08-10 | Traditional | PDF ↗ |
| K012210 | MODIFICATION TO ACCU-CHEK INFORM METER | Roche Diagnostics Corp. | 2001-08-09 | Special | PDF ↗ |
| K011616 | INDUO BLOOD GLUCOSE METER | Inverness Medical Innovations, Inc. | 2001-06-21 | Special | PDF ↗ |
| K011738 | ACCU-CHEK ACTIVE SYSTEM | Roche Diagnostics Corp. | 2001-06-20 | Special | PDF ↗ |
| K010553 | PRECISION XTRA BLOOD GLUCOSE TEST STRIP WITH TRUEMEASURE TECHNOLOGY | Abbott Laboratories | 2001-06-18 | Traditional | PDF ↗ |
| K010403 | PRESTIGE IQ BLOOD GLUCOSE TEST SYSTEM, MODEL 507400, 537600, 550600, 561700, 563700 | Home Diagnostics, Inc. | 2001-03-26 | Special | PDF ↗ |
Product code NBW · Class II · Clinical Chemistry. Data: openFDA.