The following data is part of a premarket notification filed by Siemens Medical Solutions Diagnostics with the FDA for Neonatal Bilirubin On Rapidlab Models 1245 And 1265.
| Device ID | K073537 |
| 510k Number | K073537 |
| Device Name: | NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265 |
| Classification | Bilirubin (total And Unbound) In The Neonate Test System |
| Applicant | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 2 EDGEWATER DR. Norwood, MA 02062 |
| Contact | Noor Malki |
| Correspondent | Noor Malki SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 2 EDGEWATER DR. 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 | 2007-12-17 |
| Decision Date | 2008-06-27 |
| Summary: | summary |