The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Vista Vitamin B12 And Folate Flex Reagent Cartridges And Loci 4 Calibrator.
| Device ID | K071224 |
| 510k Number | K071224 |
| Device Name: | DIMENSION VISTA VITAMIN B12 AND FOLATE FLEX REAGENT CARTRIDGES AND LOCI 4 CALIBRATOR |
| Classification | Radioassay, Vitamin B12 |
| Applicant | DADE BEHRING, INC. P.O. BOX 6101 M/S 514 Newark, DE 19714 -6101 |
| Contact | Lorraine H Piestrak |
| Correspondent | Lorraine H Piestrak DADE BEHRING, INC. P.O. BOX 6101 M/S 514 Newark, DE 19714 -6101 |
| Product Code | CDD |
| Subsequent Product Code | CGN |
| Subsequent Product Code | JIX |
| CFR Regulation Number | 862.1810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-02 |
| Decision Date | 2007-11-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768016653 | K071224 | 000 |