Submission Details
| 510(k) Number | K081769 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 23, 2008 |
| Decision Date | May 28, 2009 |
| Days to Decision | 339 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
Cleared
Traditional
INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5
May 2009
Decision
339d
Days
Class 2
Risk
About This 510(k) Submission
K081769 is an FDA 510(k) clearance for the INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5, a Antithrombin Iii Quantitation (Class II — Special Controls, product code JBQ), submitted by Siemens Healthcare Diagnostics (Newark, US). The FDA issued a Cleared decision on May 28, 2009, 339 days after receiving the submission on June 23, 2008. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7060.
Device Classification
| Product Code | JBQ — Antithrombin Iii Quantitation |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 864.7060 |
Manufacturer
Similar Devices — JBQ Antithrombin Iii Quantitation
All 55
K242952 · Siemens Healthcare Diagnostic Products GmbH
· Mar 2025
K070301 · Instrumentation Laboratory CO
· Feb 2007
K062431 · Instrumentation Laboratory CO
· Sep 2006
K043007 · Hyphen Biomed
· Nov 2005
K033775 · Instrumentation Laboratory CO
· Jan 2004
K023991 · Precision Biologic
· Apr 2003
More from Siemens Healthcare Diagnostics
View all
K243570
· JLW · Apr 2025
K162977
· GKZ · Aug 2017
K162298
· MRG · Mar 2017
K161954
· JGS · Mar 2017
K162538
· JIT · Nov 2016