The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc with the FDA for Dimension Visa Enz 2 Cal.
| Device ID | K103612 |
| 510k Number | K103612 |
| Device Name: | DIMENSION VISA ENZ 2 CAL |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS INC 500 GBC DRIVE P.O. BOX 6101 Newark, DE 19714 -6101 |
| Contact | Anna Marie K Ennis |
| Correspondent | Anna Marie K Ennis SIEMENS HEALTHCARE DIAGNOSTICS INC 500 GBC DRIVE P.O. BOX 6101 Newark, DE 19714 -6101 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-09 |
| Decision Date | 2011-01-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768034343 | K103612 | 000 |