The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Dimension Clinical Chemistry System Lipase Calibrator, Model Dc56.
| Device ID | K081319 |
| 510k Number | K081319 |
| Device Name: | DIMENSION CLINICAL CHEMISTRY SYSTEM LIPASE CALIBRATOR, MODEL DC56 |
| Classification | Calibrator, Secondary |
| Applicant | Siemens Healthcare Diagnostics Inc. 500 GBC DRIVE MS 514 Newark, DE 19702 |
| Contact | George M Plummer |
| Correspondent | George M Plummer Siemens Healthcare Diagnostics Inc. 500 GBC DRIVE MS 514 Newark, DE 19702 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-12 |
| Decision Date | 2008-08-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768025228 | K081319 | 000 |