The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Vista System A2mac Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator, Dimension Vista Sysyem.
| Device ID | K081249 |
| 510k Number | K081249 |
| Device Name: | DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM |
| Classification | Alpha-2-macroglobulin, Antigen, Antiserum, Control |
| Applicant | DADE BEHRING, INC. 500 GBC DR, MAILSTOP 514 Newark, DE 19714 -6101 |
| Contact | Anna Marie Kathleen Ennis |
| Correspondent | Anna Marie Kathleen Ennis DADE BEHRING, INC. 500 GBC DR, MAILSTOP 514 Newark, DE 19714 -6101 |
| Product Code | DEB |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 866.5620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-02 |
| Decision Date | 2008-07-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768024412 | K081249 | 000 |