The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Vista Iga Flex Reagent Cartridge Assay.
| Device ID | K061338 |
| 510k Number | K061338 |
| Device Name: | DIMENSION VISTA IGA FLEX REAGENT CARTRIDGE ASSAY |
| Classification | Method, Nephelometric, Immunoglobulins (g, A, M) |
| Applicant | DADE BEHRING, INC. P.O. BOX 6101 Newark,, DE 19714 |
| Contact | Kathleen Dray-lyons |
| Correspondent | Kathleen Dray-lyons DADE BEHRING, INC. P.O. BOX 6101 Newark,, DE 19714 |
| Product Code | CFN |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-15 |
| Decision Date | 2006-07-06 |
| Summary: | summary |