K092638 is an FDA 510(k) clearance for the FREESTYLE BLOOD GLUCOSE TEST STRIPS, MODELS 100-COUNT: 12401-01, 12101-21, 12101-22, 12101-23. This device is classified as a System, Test, Blood Glucose, Over The Counter (Class II - Special Controls, product code NBW).
Submitted by Abbott Diabetes Care, Inc. (Alameda, US). The FDA issued a Cleared decision on June 15, 2010, 292 days after receiving the submission on August 27, 2009.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K092638 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 27, 2009 |
| Decision Date | June 15, 2010 |
| Days to Decision | 292 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | NBW — System, Test, Blood Glucose, Over The Counter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1345 |