The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Advia Chemistry Drug Calibrator Ii, Model 10376771.
| Device ID | K090900 |
| 510k Number | K090900 |
| Device Name: | ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771 |
| Classification | Calibrators, Drug Mixture |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 511 Benedict Avenue Tarrytown, NY 10591 |
| Contact | Kira Gordon |
| Correspondent | Kira Gordon SIEMENS HEALTHCARE DIAGNOSTICS 511 Benedict Avenue Tarrytown, NY 10591 |
| Product Code | DKB |
| CFR Regulation Number | 862.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-01 |
| Decision Date | 2009-06-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414561332 | K090900 | 000 |