Submission Details
| 510(k) Number | K153330 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 19, 2015 |
| Decision Date | February 19, 2016 |
| Days to Decision | 92 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
FreeStyle Precision Neo H Blood Glucose Monitoring System
Feb 2016
Decision
92d
Days
Class 2
Risk
About This 510(k) Submission
K153330 is an FDA 510(k) clearance for the FreeStyle Precision Neo H 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 February 19, 2016, 92 days after receiving the submission on November 19, 2015. 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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