The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Vista C3 And C4 Flex Reagent Cartridge, Protein 1 Calibrator, Control Low, Medium, High.
| Device ID | K061852 |
| 510k Number | K061852 |
| Device Name: | DIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL LOW, MEDIUM, HIGH |
| Classification | Complement C3, 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 | CZW |
| Subsequent Product Code | DBI |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 866.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-30 |
| Decision Date | 2006-09-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768006067 | K061852 | 000 |
| 00842768006050 | K061852 | 000 |