Submission Details
| 510(k) Number | K171401 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 12, 2017 |
| Decision Date | July 11, 2017 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1
Jul 2017
Decision
60d
Days
Class 2
Risk
About This 510(k) Submission
K171401 is an FDA 510(k) clearance for the ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1, a Diazo Colorimetry, Bilirubin (Class II — Special Controls, product code CIG), submitted by Elitechgroup (Sees, FR). The FDA issued a Cleared decision on July 11, 2017, 60 days after receiving the submission on May 12, 2017. 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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