The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics, Inc. with the FDA for Advia Chemistry Albumin Bcp Reagent (albp), Advia Chemistry Albumin Bcp Calibrator.
| Device ID | K132664 |
| 510k Number | K132664 |
| Device Name: | ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP CALIBRATOR |
| Classification | Bromcresol Purple Dye-binding, Albumin |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS, INC. 511 BENEDICT AVE Tarrytown, NY 10591 |
| Contact | Kira Gordon |
| Correspondent | Kira Gordon SIEMENS HEALTHCARE DIAGNOSTICS, INC. 511 BENEDICT AVE Tarrytown, NY 10591 |
| Product Code | CJW |
| CFR Regulation Number | 862.1035 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-27 |
| Decision Date | 2013-10-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414947426 | K132664 | 000 |
| 00630414947419 | K132664 | 000 |
| 00630414947402 | K132664 | 000 |