The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Vista System Drugs Of Abuse Positive And Negative Controls, Models Kc515 And Kc516.
| Device ID | K062191 |
| 510k Number | K062191 |
| Device Name: | DIMENSION VISTA SYSTEM DRUGS OF ABUSE POSITIVE AND NEGATIVE CONTROLS, MODELS KC515 AND KC516 |
| Classification | Drug Mixture Control Materials |
| Applicant | DADE BEHRING, INC. 500 GBC DR., M/S 514 P.O. BOX 6101 Newark, DE 19714 |
| Contact | Victor M Carrio |
| Correspondent | Victor M Carrio DADE BEHRING, INC. 500 GBC DR., M/S 514 P.O. BOX 6101 Newark, DE 19714 |
| Product Code | DIF |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-31 |
| Decision Date | 2006-08-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768016479 | K062191 | 000 |
| 00842768016462 | K062191 | 000 |