The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Vista Rf Flex Reagent Cartridge; Protein 2 Calibrator And Control.
| Device ID | K062035 |
| 510k Number | K062035 |
| Device Name: | DIMENSION VISTA RF FLEX REAGENT CARTRIDGE; PROTEIN 2 CALIBRATOR AND CONTROL |
| Classification | Calibrator, Multi-analyte Mixture |
| 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 | JIX |
| Subsequent Product Code | DHR |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-19 |
| Decision Date | 2006-10-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768006234 | K062035 | 000 |