The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Vista System Drug 1 Calibrator (drug 1 Cal - Kc410).
Device ID | K062034 |
510k Number | K062034 |
Device Name: | DIMENSION VISTA SYSTEM DRUG 1 CALIBRATOR (DRUG 1 CAL - KC410) |
Classification | Calibrator, Multi-analyte Mixture |
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 | JIX |
CFR Regulation Number | 862.1150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-07-19 |
Decision Date | 2006-09-06 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00842768015762 | K062034 | 000 |