Submission Details
| 510(k) Number | K181527 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 11, 2018 |
| Decision Date | October 03, 2018 |
| Days to Decision | 114 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring System
Oct 2018
Decision
114d
Days
Class 2
Risk
About This 510(k) Submission
K181527 is an FDA 510(k) clearance for the On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring System, a System, Test, Blood Glucose, Over The Counter (Class II — Special Controls, product code NBW), submitted by ACON Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on October 3, 2018, 114 days after receiving the submission on June 11, 2018. 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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