The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Vista Ferritin Flex Reagent Cartridge (ferr).
| Device ID | K070552 |
| 510k Number | K070552 |
| Device Name: | DIMENSION VISTA FERRITIN FLEX REAGENT CARTRIDGE (FERR) |
| Classification | Calibrator, Secondary |
| Applicant | DADE BEHRING, INC. P.O. BOX 6101 MS 514 Newark, DE 19714 |
| Contact | Lorraine H Piestrak |
| Correspondent | Lorraine H Piestrak DADE BEHRING, INC. P.O. BOX 6101 MS 514 Newark, DE 19714 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-27 |
| Decision Date | 2007-04-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768015182 | K070552 | 000 |