Submission Details
| 510(k) Number | K061107 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 20, 2006 |
| Decision Date | August 08, 2006 |
| Days to Decision | 110 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
Cleared
Traditional
DPC T60I KUSTI, MODEL 984248; DPC T60I, MODEL 984247
Aug 2006
Decision
110d
Days
Class 2
Risk
About This 510(k) Submission
K061107 is an FDA 510(k) clearance for the DPC T60I KUSTI, MODEL 984248; DPC T60I, MODEL 984247, a Electrode, Ion Specific, Potassium (Class II — Special Controls, product code CEM), submitted by Thermo Electron OY (Vantaa, FI). The FDA issued a Cleared decision on August 8, 2006, 110 days after receiving the submission on April 20, 2006. 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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