Submission Details
| 510(k) Number | K123010 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 27, 2012 |
| Decision Date | December 14, 2012 |
| Days to Decision | 78 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEM
Dec 2012
Decision
78d
Days
Class 2
Risk
About This 510(k) Submission
K123010 is an FDA 510(k) clearance for the ON CALL VIVID 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 14, 2012, 78 days after receiving the submission on September 27, 2012. 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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