| Tina-Quant Ceruloplasmin | K091741 | FDA 510(k) | Class II | Active |
| Roche Diagnostics Tina-Quant Igg Gen.2 | K040434 | FDA 510(k) | Class II | Active |
| Preciset Dat Plus Ii And Cfas Dat Qualitative Plus Calibrators | K033306 | FDA 510(k) | Class II | Active |
| Tina-quant Cardiac high sensitivity CRP III | K260026 | FDA 510(k) | Class II | Active |
| Elecsys Precicontrol Bone | K051543 | FDA 510(k) | Class I | Active |
| Anti-Hav Igm | K093955 | FDA 510(k) | Class II | Active |
| Ontrak Teststik For Pcp, Cat. 07 6654 2 | K994020 | FDA 510(k) | U | Active |
| Elecsys Tacrolimus | K173857 | FDA 510(k) | Class II | Active |
| Accu-Chek Active System | K011738 | FDA 510(k) | Class II | Active |
| Tina-Quant Transferrin Ver.2 | K012371 | FDA 510(k) | Class II | Active |
| Online Dat Ii Cannabinoids Ii | K030213 | FDA 510(k) | Class II | Active |
| Elecsys Thyroglobulin Calcheck | K001015 | FDA 510(k) | Class I | Active |
| Elecsys Ca 125 Ii Calcheck 5 | K102086 | FDA 510(k) | Class I | Active |
| Modification To Precinorm Universal Plus And Precipath Universal Plus Control Sera | K042389 | FDA 510(k) | Class I | Active |
| Accu-Chek Advantage Meter | K000365 | FDA 510(k) | Class II | Active |
| Elecys Hgh Calset, Elecsys Hgh Calcheck 5 | K103221 | FDA 510(k) | Class II | Active |
| Elecsys N-Mid Osteocalcin Calcheck 5 | K112104 | FDA 510(k) | Class I | Active |
| Elecsys Pth Calcheck 5 | K103162 | FDA 510(k) | Class I | Active |
| Precinorm Universal And Precipath Universal Control Sera | K992900 | FDA 510(k) | Class I | Active |
| Cobas Integra Glucose Hk Gen 3 Assay | K092603 | FDA 510(k) | Class II | Active |
| Cobas Integra Glucose Hk Gen. 3 Test System | K061048 | FDA 510(k) | Class II | Active |
| Elecsys Anti-Tshr Immunoassay, Elecsys Precicontrol Thyroab | K080092 | FDA 510(k) | Class II | Active |
| Elecsys Ca 15-3 Ii Calcheck 5 | K122242 | FDA 510(k) | Class I | Active |
| Online Tdm Carbamazepine | K031902 | FDA 510(k) | Class II | Active |
| Creatine Kinase-MB | K162526 | FDA 510(k) | Class II | Active |
| ROMA Calculation Tool Using Elecsys Assays | K153607 | FDA 510(k) | Class II | Active |
| Elecsys Lh Calcheck 5 | K121279 | FDA 510(k) | Class I | Active |
| cobas u 701 microscopy analyzer | K200811 | FDA 510(k) | Class II | Active |
| Elecsys Probnp Immunoassay | K051382 | FDA 510(k) | Class II | Active |
| Elecsys Precicontrol Universal | K090541 | FDA 510(k) | Class I | Active |
| Cobas Amplicor Ct/Ng Test For Neisseria Gonorrhoeae | K053289 | FDA 510(k) | Class II | Active |
| Tina-Quant Complement C3c Test System | K012361 | FDA 510(k) | Class II | Active |
| Roche Online Tdm Lidocaine | K032334 | FDA 510(k) | Class II | Active |
| Iron Standard | K052002 | FDA 510(k) | Class II | Active |
| Elecsys Lh Calset Ii | K031299 | FDA 510(k) | Class II | Active |
| Cobas 8000 Ise Indirect Na, K, Ci For Gen. 2 | K123726 | FDA 510(k) | Class II | Active |
| Elecys Anti-Ccp Calcheck | K091601 | FDA 510(k) | Class I | Active |
| Camit Diabetes Management Software | K001907 | FDA 510(k) | Class II | Active |
| Tina-Quant Apolipoprotein Ver.2 | K013249 | FDA 510(k) | Class II | Active |
| Roche Online Tdm Quinidine | K032332 | FDA 510(k) | Class II | Active |
| C.f.a.s. (calibrator For Automated Systems) Hba1c | K052101 | FDA 510(k) | Class II | Active |
| Elecsys Rubella Igga Calcheck 5 | K092585 | FDA 510(k) | Class I | Active |
| Calibrator For Automated Systems (c.f.a.s.) | K990460 | FDA 510(k) | Class II | Active |
| Elecsys Ca 19-9 Calcheck | K051185 | FDA 510(k) | Class I | Active |
| Online Valproic Acid | K060690 | FDA 510(k) | Class II | Active |
| Roche Diagnostics Elecsys Precicontrol Tumor | K050387 | FDA 510(k) | Class I | Active |
| Calibrator For Automated Systems Prealbumin-Aslo-Ceruloplasmin (c.f.a.s. Pac) | K040245 | FDA 510(k) | Class II | Active |
| Elecsys Probnp Immunoassay | K032646 | FDA 510(k) | Class II | Active |
| Roche Oral Fluid Cocaine | K101160 | FDA 510(k) | Class II | Active |
| Modification To:roche Diagnostics Tina-Quant Rheumatoid Factors Ii Test System | K032535 | FDA 510(k) | Class II | Active |