Submission Details
| 510(k) Number | K130284 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 05, 2013 |
| Decision Date | December 20, 2013 |
| Days to Decision | 318 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
ON CALL SHARP BLOOD GLUCOSE MONITORING SYSTEM
Dec 2013
Decision
318d
Days
Class 2
Risk
About This 510(k) Submission
K130284 is an FDA 510(k) clearance for the ON CALL SHARP 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 December 20, 2013, 318 days after receiving the submission on February 5, 2013. 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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