Submission Details
| 510(k) Number | K072717 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 25, 2007 |
| Decision Date | December 12, 2007 |
| Days to Decision | 78 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
DIMENSION VISTA SYSTEM BILIRUBIN CALIBRATOR, MODEL KC210
Dec 2007
Decision
78d
Days
Class 2
Risk
About This 510(k) Submission
K072717 is an FDA 510(k) clearance for the DIMENSION VISTA SYSTEM BILIRUBIN CALIBRATOR, MODEL KC210, a Calibrator, Secondary (Class II — Special Controls, product code JIT), submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on December 12, 2007, 78 days after receiving the submission on September 25, 2007. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.
Device Classification
| Product Code | JIT — Calibrator, Secondary |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1150 |
Manufacturer
Similar Devices — JIT Calibrator, Secondary
All 244
K171168 · Ortho-Clinical Diagnostics
· May 2017
K170938 · Roche Diagnostics
· Apr 2017
K170160 · Abbott Laboratories
· Feb 2017
K163534 · Fujirebio Diagnostics,Inc.
· Jan 2017
K163546 · Fujirebio Diagnostics,Inc.
· Jan 2017
K163521 · Fujirebio Diagnostics,Inc.
· Jan 2017
More from Dade Behring, Inc.
View all
K093848
· GGN · Dec 2010
K081161
· CFN · Jul 2008
K081249
· DEB · Jul 2008
K071603
· DHX · Jun 2008
K071597
· LOJ · Jun 2008