The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Vista Cysc Flex Reagent Cartridge, Protein 3 Calibrator And Cystatin Control Low And High.
| Device ID | K063351 |
| 510k Number | K063351 |
| Device Name: | DIMENSION VISTA CYSC FLEX REAGENT CARTRIDGE, PROTEIN 3 CALIBRATOR AND CYSTATIN CONTROL LOW AND HIGH |
| Classification | Test, Cystatin C |
| Applicant | DADE BEHRING, INC. P.O. BOX 6101 Newark,, DE 19714 |
| Contact | Kathleen A Dray-lyons |
| Correspondent | Kathleen A Dray-lyons DADE BEHRING, INC. P.O. BOX 6101 Newark,, DE 19714 |
| Product Code | NDY |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-06 |
| Decision Date | 2007-01-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768006104 | K063351 | 000 |
| 00842768006395 | K063351 | 000 |
| 00842768006388 | K063351 | 000 |