Submission Details
| 510(k) Number | K151595 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 12, 2015 |
| Decision Date | September 05, 2015 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
On Call Express Pro Blood Glucose Monitoring System
Sep 2015
Decision
85d
Days
Class 2
Risk
About This 510(k) Submission
K151595 is an FDA 510(k) clearance for the On Call Express Pro 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 September 5, 2015, 85 days after receiving the submission on June 12, 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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