The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Vista Protein 1 Calibrator And Control L, M, H; Protein 2 Calibrator And Control L, H; Protein 3 Calibrator An.
| Device ID | K063508 |
| 510k Number | K063508 |
| Device Name: | DIMENSION VISTA PROTEIN 1 CALIBRATOR AND CONTROL L, M, H; PROTEIN 2 CALIBRATOR AND CONTROL L, H; PROTEIN 3 CALIBRATOR AN |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | DADE BEHRING, INC. P.O. BOX 6101 Newark,, DE 19714 |
| Contact | Helen M Lee |
| Correspondent | Helen M Lee DADE BEHRING, INC. P.O. BOX 6101 Newark,, DE 19714 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-20 |
| Decision Date | 2007-01-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768006463 | K063508 | 000 |
| 00842768006487 | K063508 | 000 |
| 00842768006470 | K063508 | 000 |