K010052 is an FDA 510(k) clearance for the RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20. This device is classified as a Bilirubin (total And Unbound) In The Neonate Test System (Class I - General Controls, product code MQM).
Submitted by Respironics, Inc. (Kennesaw, US). The FDA issued a Cleared decision on March 19, 2001, 70 days after receiving the submission on January 8, 2001.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1113.
| 510(k) Number | K010052 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 08, 2001 |
| Decision Date | March 19, 2001 |
| Days to Decision | 70 days |
| Submission Type | Abbreviated |
| 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 |