The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Ctni Calibrator.
| Device ID | K010314 |
| 510k Number | K010314 |
| Device Name: | DIMENSION CTNI CALIBRATOR |
| Classification | Calibrator, Secondary |
| Applicant | DADE BEHRING, INC. P.O. BOX 6101, BUILDING 500 Newark, DE 19714 |
| Contact | George Plummer |
| Correspondent | George Plummer DADE BEHRING, INC. P.O. BOX 6101, BUILDING 500 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 | 2001-02-02 |
| Decision Date | 2001-04-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768013713 | K010314 | 000 |