The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Dimension Vista Csae Flex Regent Cartridge, Model K4108.
| Device ID | K081992 |
| 510k Number | K081992 |
| Device Name: | DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108 |
| Classification | Cyclosporine |
| Applicant | Siemens Healthcare Diagnostics Inc. PO BOX 6101 Newark, DE 19714 -6101 |
| Contact | Yuk-ting Lewis |
| Correspondent | Yuk-ting Lewis Siemens Healthcare Diagnostics Inc. PO BOX 6101 Newark, DE 19714 -6101 |
| Product Code | MKW |
| CFR Regulation Number | 862.1235 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-14 |
| Decision Date | 2008-08-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768016035 | K081992 | 000 |