Submission Details
| 510(k) Number | K050928 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 14, 2005 |
| Decision Date | June 29, 2005 |
| Days to Decision | 76 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
Cleared
Traditional
DADE THROMBIN REAGENT
Jun 2005
Decision
76d
Days
Class 2
Risk
About This 510(k) Submission
K050928 is an FDA 510(k) clearance for the DADE THROMBIN REAGENT, a System, Fibrinogen Determination (Class II — Special Controls, product code KQJ), submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on June 29, 2005, 76 days after receiving the submission on April 14, 2005. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7340.
Device Classification
| Product Code | KQJ — System, Fibrinogen Determination |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 864.7340 |
Manufacturer
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