Submission Details
| 510(k) Number | K140371 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 14, 2014 |
| Decision Date | September 30, 2014 |
| Days to Decision | 228 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
FREESTYLE PRECISION NEO BLOOD GLUCOSE: MONITORING SYSTEM, TEST STRIPS (50CT), TEST STRIPS (100CT)
Sep 2014
Decision
228d
Days
Class 2
Risk
About This 510(k) Submission
K140371 is an FDA 510(k) clearance for the FREESTYLE PRECISION NEO BLOOD GLUCOSE: MONITORING SYSTEM, TEST STRIPS (50CT), TEST STRIPS (100CT), 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 September 30, 2014, 228 days after receiving the submission on February 14, 2014. 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
Similar Devices — NBW System, Test, Blood Glucose, Over The Counter
All 507
K250085 · ACON Laboratories, Inc.
· Oct 2025
K243060 · Guangdong Transtek Medical Electronics Co., Ltd.
· Jan 2025
K240637 · Bionime Corporation
· Nov 2024
K240640 · Sejoy Biomedical Co., Ltd.
· Oct 2024
K241787 · Ascensia Diabetes Care U.S., Inc.
· Aug 2024
K222126 · Vivachek Biotech (Hangzhou) Co., Ltd.
· Aug 2024
More from Abbott Diabetes Care, Inc.
View all
K233537
· QBJ · Apr 2024
K223435
· QBJ · Apr 2023
K222447
· QBJ · Mar 2023
K223537
· QLG · Feb 2023
K212132
· QLG · May 2022