Submission Details
| 510(k) Number | K110780 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 21, 2011 |
| Decision Date | October 07, 2011 |
| Days to Decision | 200 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
ELITECH CLINICAL SYSTEMS BILIRUBIN TOTAL 4+1, ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTMES ELITROL I & II
Oct 2011
Decision
200d
Days
Class 2
Risk
About This 510(k) Submission
K110780 is an FDA 510(k) clearance for the ELITECH CLINICAL SYSTEMS BILIRUBIN TOTAL 4+1, ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTMES ELITROL I & II, a Diazo Colorimetry, Bilirubin (Class II — Special Controls, product code CIG), submitted by Elitechgroup (Bothell, US). The FDA issued a Cleared decision on October 7, 2011, 200 days after receiving the submission on March 21, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1110.
Device Classification
| Product Code | CIG — Diazo Colorimetry, Bilirubin |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1110 |
Manufacturer
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