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 |