Panels › Clinical Chemistry › Product code NBW · Class 2
System, Test, Blood Glucose, Over The Counter
Regulation 862.1345
6510(k)s in 12 months (514 all time)
4recalls in 12 months (137 all time)
100recalls that name a 510(k)
Top companies in NBW
| Company | 510(k)s | Recalls |
|---|---|---|
| Taidoc Technology Corporation | 65 | 0 |
| Abbott Diabetes Care | 19 | 22 |
| Lifescan, Inc. | 13 | 17 |
| Roche Diagnostics | 19 | 8 |
| I-Sens, Inc. | 22 | 0 |
| Apex BioTechnology Corp. | 18 | 0 |
| Bionime Corporation | 18 | 0 |
| Roche Diabetes Care | 4 | 13 |
| Nova Biomedical Corp. | 6 | 10 |
| EPS Bio Technology Corp. | 15 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 28, 2002 | K012975 | SOF-TACT DIABETES MANAGEMENT SYSYEM; SOF-TACT BLOOD GLUCOSE TEST STRIP; PRECISION CONTROL SOLUTIONS Abbott Laboratories | NBW |
| Feb 19, 2002 | K014167 | LIBERTY BLOOD GLUCOSE MONITORING SYSTEM Polymedica Pharmaceuticals, U.S.A., Inc.] | NBW |
| Dec 21, 2001 | K014099 | BIOSCANNER PLUS Polymer Technology Systems, Inc. | NBW |
| Dec 5, 2001 | K012324 | ACCU-CHEK ACTIVE TEST SYSTEM Roche Diagnostics Corp. | NBW |
| Dec 5, 2001 | K012014 | MODIFICATION TO BLOOD GLUCOSE MONITORING SYSTEM Abbott Diabetes Care, Inc. | NBW |
| Nov 16, 2001 | K013203 | BIOSCANNER BEYOND GLUCOSE ANALYZER AND TEST STRIPS Polymer Technology Systems, Inc. | NBW |
| Sep 13, 2001 | K011240 | EVENCARE BLOOD GLUCOSE MONITORING SYSTEM Medline Industries, Inc. | NBW |
| Sep 12, 2001 | K012205 | GLUCOMETER DEX TEST SENSOR Bayer Corp. | NBW |
| Aug 10, 2001 | K010039 | QUICKTEK BLOOD GLUCOSE SYSTEM, QUICKTEK BLOOD GLUCOSE METER, QUICKTEK BLOOD GLUCOSE STRIPS, QUICKTEK CONTROL SOLUTION Chronimed, Inc. | NBW |
| Aug 9, 2001 | K012210 | MODIFICATION TO ACCU-CHEK INFORM METER Roche Diagnostics Corp. | NBW |
| Jun 21, 2001 | K011616 | INDUO BLOOD GLUCOSE METER Inverness Medical Innovations, Inc. | NBW |
| Jun 20, 2001 | K011738 | ACCU-CHEK ACTIVE SYSTEM Roche Diagnostics Corp. | NBW |
| Jun 18, 2001 | K010553 | PRECISION XTRA BLOOD GLUCOSE TEST STRIP WITH TRUEMEASURE TECHNOLOGY Abbott Laboratories | NBW |
| Mar 26, 2001 | K010403 | PRESTIGE IQ BLOOD GLUCOSE TEST SYSTEM, MODEL 507400, 537600, 550600, 561700, 563700 Home Diagnostics, Inc. | NBW |
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