The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Rapidpoint 405 Neonatal Bilirubin.
| Device ID | K110277 |
| 510k Number | K110277 |
| Device Name: | RAPIDPOINT 405 NEONATAL BILIRUBIN |
| Classification | Bilirubin (total And Unbound) In The Neonate Test System |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 2 EDGEWATER DRIVE Norwood, MA 02062 |
| Contact | Steven Goldberg |
| Correspondent | Steven Goldberg SIEMENS HEALTHCARE DIAGNOSTICS 2 EDGEWATER DRIVE Norwood, MA 02062 |
| Product Code | MQM |
| CFR Regulation Number | 862.1113 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-31 |
| Decision Date | 2011-08-15 |
| Summary: | summary |