Submission Details
| 510(k) Number | K132511 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 12, 2013 |
| Decision Date | December 24, 2013 |
| Days to Decision | 134 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Special
FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM
Dec 2013
Decision
134d
Days
Class 2
Risk
About This 510(k) Submission
K132511 is an FDA 510(k) clearance for the FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE 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 December 24, 2013, 134 days after receiving the submission on August 12, 2013. 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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