The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Advia Centaur Shbg Readypack, Low And High Calibrators And Master Curve Material, Models 06520781, 04819274 And 06520773.
| Device ID | K091867 |
| 510k Number | K091867 |
| Device Name: | ADVIA CENTAUR SHBG READYPACK, LOW AND HIGH CALIBRATORS AND MASTER CURVE MATERIAL, MODELS 06520781, 04819274 AND 06520773 |
| Classification | Radioimmunoassay, Testosterones And Dihydrotestosterone |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 511 Benedict Avenue Tarrytown, NY 10591 |
| Contact | Clare Santulli |
| Correspondent | Clare Santulli SIEMENS HEALTHCARE DIAGNOSTICS 511 Benedict Avenue Tarrytown, NY 10591 |
| Product Code | CDZ |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-23 |
| Decision Date | 2010-01-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414556093 | K091867 | 000 |