The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Respironics Bilichek Non-invasive-100-0800-20; Bilirubin Analyzer.
| Device ID | K010052 |
| 510k Number | K010052 |
| Device Name: | RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANALYZER |
| Classification | Bilirubin (total And Unbound) In The Neonate Test System |
| Applicant | RESPIRONICS, INC. 125 CHASTAIN MEADOW COURT Kennesaw, GA 30144 -3724 |
| Contact | David J Vanella |
| Correspondent | David J Vanella RESPIRONICS, INC. 125 CHASTAIN MEADOW COURT Kennesaw, GA 30144 -3724 |
| Product Code | MQM |
| CFR Regulation Number | 862.1113 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-08 |
| Decision Date | 2001-03-19 |