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US
Last updated May 23, 2026
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Catalogue (72)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Von Willebrand Fac. Defic. Abnormal Control Plasma | K860751 | FDA 510(k) | Class II | Active |
| Physiologic Saline (0.85%) | K761174 | FDA 510(k) | Class I | Active |
| Citrex I | K853076 | FDA 510(k) | Class II | Active |
| Hpc Tm (heparinized Plasma Control) | K770188 | FDA 510(k) | Class II | Active |
| Reptilase -pc | K843207 | FDA 510(k) | Class II | Active |
| Plastinex | K852484 | FDA 510(k) | Class II | Active |
| Citrex Iii | K853078 | FDA 510(k) | Class II | Active |
| Sodium Citrate | K761177 | FDA 510(k) | Class II | Active |
| Thrombolytic Activity Test | K834301 | FDA 510(k) | Class II | Active |
| Low Fibrinogen Control | K812108 | FDA 510(k) | Class II | Active |
| Citrex Ii | K853077 | FDA 510(k) | Class II | Active |
| Veronal Buffer | K761171 | FDA 510(k) | Class II | Active |
| Tris Buffered Saline | K761172 | FDA 510(k) | Class II | Active |
| Microsample Coagulation Analyser, Model 110wp | K860342 | FDA 510(k) | Class II | Active |
| Platelet Aggregation Profiler #pap-4 | K821005 | FDA 510(k) | Class II | Active |
| Tris Buffered | K761173 | FDA 510(k) | Class II | Active |
| Kinetic Fibrinogen Assay | K881150 | FDA 510(k) | Class II | Active |
| Tpc-Lyophilized Pooled Human Plasma | K761091 | FDA 510(k) | Class II | Active |
| Microsample Coagulation Analyzer | K943153 | FDA 510(k) | Class II | Active |
| Quan-8 Mult-Comp Factor Viii Assay Kit | K761058 | FDA 510(k) | Class II | Active |
| Platelet Extract Reagent | K873382 | FDA 510(k) | Class II | Active |
| Cephalinex Activated Ptt Reagent | K852195 | FDA 510(k) | Class II | Active |
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