Submission Details
| 510(k) Number | K120568 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 27, 2012 |
| Decision Date | March 29, 2012 |
| Days to Decision | 31 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Special
FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM
Mar 2012
Decision
31d
Days
Class 2
Risk
About This 510(k) Submission
K120568 is an FDA 510(k) clearance for the FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM, 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 March 29, 2012, 31 days after receiving the submission on February 27, 2012. 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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