The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Vista Chemistry 3 Calibrator, Model Kc130.
Device ID | K062334 |
510k Number | K062334 |
Device Name: | DIMENSION VISTA CHEMISTRY 3 CALIBRATOR, MODEL KC130 |
Classification | Calibrator, Multi-analyte Mixture |
Applicant | DADE BEHRING, INC. P.O. BOX BOX 6101, M/S 514 Newark, DE 19714 -6101 |
Contact | Victor M Carrio |
Correspondent | Victor M Carrio DADE BEHRING, INC. P.O. BOX BOX 6101, M/S 514 Newark, DE 19714 -6101 |
Product Code | JIX |
CFR Regulation Number | 862.1150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-08-10 |
Decision Date | 2006-09-22 |
Summary: | summary |