The following data is part of a premarket notification filed by Siemens Medical Solutions Diagnostics with the FDA for Advia Chemistry Enzymatic Creatinine_2.
| Device ID | K070727 |
| 510k Number | K070727 |
| Device Name: | ADVIA CHEMISTRY ENZYMATIC CREATININE_2 |
| Classification | Enzymatic Method, Creatinine |
| Applicant | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 511 Benedict Avenue Tarrytown, NY 10591 |
| Contact | Philip Liu |
| Correspondent | Philip Liu SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 511 Benedict Avenue Tarrytown, NY 10591 |
| Product Code | JFY |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-15 |
| Decision Date | 2007-08-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414595795 | K070727 | 000 |
| 00630414526690 | K070727 | 000 |