The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Dimension Clinical Chemistry System Enzyme I Calibrator.
| Device ID | K081789 |
| 510k Number | K081789 |
| Device Name: | DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR |
| Classification | Calibrator, Secondary |
| Applicant | Siemens Healthcare Diagnostics Inc. 500 GBC DRIVE MS 514 Newark, DE 19714 -6101 |
| Contact | Helen M Lee |
| Correspondent | Helen M Lee Siemens Healthcare Diagnostics Inc. 500 GBC DRIVE MS 514 Newark, DE 19714 -6101 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-25 |
| Decision Date | 2008-09-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768026218 | K081789 | 000 |