The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Vista System Drugs Of Abuse Calibrator (udat Cal - Kc510).
| Device ID | K062162 |
| 510k Number | K062162 |
| Device Name: | DIMENSION VISTA SYSTEM DRUGS OF ABUSE CALIBRATOR (UDAT CAL - KC510) |
| Classification | Calibrators, Drug Mixture |
| Applicant | DADE BEHRING, INC. P.O. BOX 6101 Newark, DE 19714 |
| Contact | Victor M Carrio |
| Correspondent | Victor M Carrio DADE BEHRING, INC. P.O. BOX 6101 Newark, DE 19714 |
| Product Code | DKB |
| CFR Regulation Number | 862.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-28 |
| Decision Date | 2006-09-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768016455 | K062162 | 000 |