The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Vista System Alkaline Phosphatase Calibrator (alp Cal - Kc330).
Device ID | K061818 |
510k Number | K061818 |
Device Name: | DIMENSION VISTA SYSTEM ALKALINE PHOSPHATASE CALIBRATOR (ALP CAL - KC330) |
Classification | Calibrator, Secondary |
Applicant | DADE BEHRING, INC. P.O. BOX 6101 Newark, DE 19714 |
Contact | Victor M Carrio |
Correspondent | Victor M Carrio DADE BEHRING, INC. P.O. BOX 6101 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 | 2006-06-28 |
Decision Date | 2006-07-18 |
Summary: | summary |