Submission Details
| 510(k) Number | K110830 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 25, 2011 |
| Decision Date | June 21, 2011 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO; ELITECH CLINICAL SYSTEMS ALBUMIN; ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH
Jun 2011
Decision
88d
Days
Class 2
Risk
About This 510(k) Submission
K110830 is an FDA 510(k) clearance for the ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO; ELITECH CLINICAL SYSTEMS ALBUMIN; ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH, a Bromcresol Green Dye-binding, Albumin (Class II — Special Controls, product code CIX), submitted by Elitechgroup (Bothell, US). The FDA issued a Cleared decision on June 21, 2011, 88 days after receiving the submission on March 25, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1035.
Device Classification
| Product Code | CIX — Bromcresol Green Dye-binding, Albumin |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1035 |
Manufacturer
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