Submission Details
| 510(k) Number | K090628 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 09, 2009 |
| Decision Date | December 04, 2009 |
| Days to Decision | 270 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080
Dec 2009
Decision
270d
Days
Class 2
Risk
About This 510(k) Submission
K090628 is an FDA 510(k) clearance for the DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080, a System, Test, Blood Glucose, Over The Counter (Class II — Special Controls, product code NBW), submitted by Bayer Healthcare, LLC (Tarrytown, US). The FDA issued a Cleared decision on December 4, 2009, 270 days after receiving the submission on March 9, 2009. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.
Device Classification
| Product Code | NBW — System, Test, Blood Glucose, Over The Counter |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1345 |
Manufacturer
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