Submission Details
| 510(k) Number | K180196 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 24, 2018 |
| Decision Date | March 07, 2018 |
| Days to Decision | 42 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
Cleared
Special
On Call Express Mobile Blood Glucose Monitoring System
Mar 2018
Decision
42d
Days
Class 2
Risk
About This 510(k) Submission
K180196 is an FDA 510(k) clearance for the On Call Express Mobile 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 March 7, 2018, 42 days after receiving the submission on January 24, 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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