K133175 is an FDA 510(k) clearance for the DRAEGER JAUNDICE METER JM-105. This device is classified as a Bilirubin (total And Unbound) In The Neonate Test System (Class I - General Controls, product code MQM).
Submitted by Draeger Medical Systems, Inc. (Telford, US). The FDA issued a Cleared decision on November 13, 2014, 392 days after receiving the submission on October 17, 2013.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1113.
| 510(k) Number | K133175 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 17, 2013 |
| Decision Date | November 13, 2014 |
| Days to Decision | 392 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | MQM — Bilirubin (total And Unbound) In The Neonate Test System |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1113 |