Submission Details
| 510(k) Number | K111960 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 11, 2011 |
| Decision Date | November 18, 2011 |
| Days to Decision | 130 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
ELITECH CLINICAL SYSTEMS CARBON DIOXIDE ELECTRODE, ELITECH CLINICAL SYSTEMS ISE CALIBRATORS
Nov 2011
Decision
130d
Days
Class 2
Risk
About This 510(k) Submission
K111960 is an FDA 510(k) clearance for the ELITECH CLINICAL SYSTEMS CARBON DIOXIDE ELECTRODE, ELITECH CLINICAL SYSTEMS ISE CALIBRATORS, a Enzymatic, Carbon-dioxide (Class II — Special Controls, product code KHS), submitted by Elitechgroup (Bothell, US). The FDA issued a Cleared decision on November 18, 2011, 130 days after receiving the submission on July 11, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1160.
Device Classification
| Product Code | KHS — Enzymatic, Carbon-dioxide |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1160 |
Manufacturer
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