The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Vista Microalbumin Flex Reagent Cartridge; Protein 3 Calibrator; Protein 3 Control.
| Device ID | K061990 |
| 510k Number | K061990 |
| Device Name: | DIMENSION VISTA MICROALBUMIN FLEX REAGENT CARTRIDGE; PROTEIN 3 CALIBRATOR; PROTEIN 3 CONTROL |
| Classification | Albumin, Antigen, Antiserum, Control |
| 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 | DCF |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 866.5040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-13 |
| Decision Date | 2006-09-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768006203 | K061990 | 000 |