The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Advia Chemistry Lipoprotein(a) Reagent Advia Chemistry Lipoprotein(a) Calibrator.
| Device ID | K123046 |
| 510k Number | K123046 |
| Device Name: | ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATOR |
| Classification | Lipoprotein, Low-density, Antigen, Antiserum, Control |
| Applicant | Siemens Healthcare Diagnostics Inc. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Contact | Neil Parker |
| Correspondent | Neil Parker Siemens Healthcare Diagnostics Inc. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Product Code | DFC |
| CFR Regulation Number | 866.5600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-28 |
| Decision Date | 2012-12-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414597546 | K123046 | 000 |
| 00630414595559 | K123046 | 000 |
| 00630414558257 | K123046 | 000 |
| 00630414558080 | K123046 | 000 |