Submission Details
| 510(k) Number | K121040 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 05, 2012 |
| Decision Date | August 30, 2012 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
SMARTLYTE ELECTROLYTE ANALYZER
Aug 2012
Decision
147d
Days
Class 2
Risk
About This 510(k) Submission
K121040 is an FDA 510(k) clearance for the SMARTLYTE ELECTROLYTE ANALYZER, a Electrode, Ion Specific, Potassium (Class II — Special Controls, product code CEM), submitted by Diamond Diagnostics, Inc. (Holliston, US). The FDA issued a Cleared decision on August 30, 2012, 147 days after receiving the submission on April 5, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1600.
Device Classification
| Product Code | CEM — Electrode, Ion Specific, Potassium |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1600 |
Manufacturer
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