| Liquichek Urianlysis Control (cat. No. 420, 421, 422, 425, 426) | K965171 | FDA 510(k) | Class I | Active |
| Liquichek Urine Toxicology Control (confirmatory Series) | K033404 | FDA 510(k) | Class I | Active |
| Liquichek Ana Control, Speckled Pattern, Positive, Catalog #108 | K024217 | FDA 510(k) | Class II | Active |
| Manual Phenylalanine Test | K963040 | FDA 510(k) | Class II | Active |
| Digilab Cambridge Perimeter | K860115 | FDA 510(k) | Class I | Active |
| Benzodiazepines And Tricyclic Antidepressants By Hplc | K941994 | FDA 510(k) | Class II | Active |
| Liquichek Blood Gas Plus Co-Oximeter Control (800 Series), Model504, 505, 506 | K003239 | FDA 510(k) | Class I | Active |
| Lyphochek Glycated Hemoglobin/Whole Blood/Lev.i&Ii | K862186 | FDA 510(k) | Class II | Active |
| Hemoglobin Alc By Column Test | K822977 | FDA 510(k) | Class II | Active |
| Architect Free T3 Mastercheck, Model Number 6c48-05 | K984319 | FDA 510(k) | Class I | Active |
| Radias Red Cell Folate Immunoasay | K944212 | FDA 510(k) | Class II | Active |
| Lyphochek Urine Toxicology Control - Low | K881990 | FDA 510(k) | Class I | Active |
| Lyphochek Hemoglobin Aic Control Human | K831478 | FDA 510(k) | Class II | Active |
| Remedi(tm) Drug Profiling System, Modification | K911954 | FDA 510(k) | Class II | Active |
| Lyphochek Spinal Fluid Control (human) | K880494 | FDA 510(k) | Class I | Active |
| Lyphochek Anemia Control, Model 500 | K992741 | FDA 510(k) | Class I | Active |
| Lyphocheck Urine Metals Control, Item No.400, 405 | K990928 | FDA 510(k) | Class I | Active |
| Liquichek Qualitative Urine Toxicology Control, Negative, Model 454; Positive, Model 455 | K033366 | FDA 510(k) | Class I | Active |
| Architech Afp Mastercheck, Model 6c01-05 | K992781 | FDA 510(k) | Class I | Active |
| Digilab 350 The Krakau Perimeter | K832175 | FDA 510(k) | Class I | Active |
| Lyphochek Urine Toxicology Control | K881989 | FDA 510(k) | Class I | Active |
| Quantaphase Ii B12/Folate | K935286 | FDA 510(k) | Class II | Active |
| Ria, Quantimune E3 | K781850 | FDA 510(k) | Class I | Active |
| Variant(tm) Hemoglobin A 1c Program | K926469 | FDA 510(k) | Class II | Active |
| Lyphochek Immunoassay Serum Control Level I, Ii, Iii | K864137 | FDA 510(k) | Class I | Active |
| Liquichek Ana Control, Centromere Pattern, Model 203 | K984397 | FDA 510(k) | Class II | Active |
| Lyphochek Whole Blood Control | K980871 | FDA 510(k) | Class I | Active |
| Bio-Rad Platelia Toxo Igm Tmb | K013837 | FDA 510(k) | Class II | Active |
| Quantimune Hlh Ria | K821346 | FDA 510(k) | Class I | Active |
| Digilab Model 1500 Perimeter | K870120 | FDA 510(k) | Class I | Active |
| Liquichek Hematology Control (a) | K041457 | FDA 510(k) | Class II | Active |
| Liquichek Ck/Ld Isoenzyme Control; Levels 1 And 2 | K903430 | FDA 510(k) | Class I | Active |
| Lyphochek Assayed Chemistry Control (human), I/Ii | K874280 | FDA 510(k) | Class I | Active |
| Test, Ria, Tsh Quantimune | K760132 | FDA 510(k) | Class II | Active |
| Lyphochek Therapeutic Drug Monitoring Control | K880145 | FDA 510(k) | Class I | Active |
| Radias Ana Screen Enzyme Immunoassay | K941509 | FDA 510(k) | Class II | Active |
| Quantimune Tobramycin Ria Radioimmuno | K791502 | FDA 510(k) | Class II | Active |
| Quantimune Neonatal & Thyroxine Ria | K771135 | FDA 510(k) | Class II | Active |
| Architect Testosterone Mastercheck, Model 6c28-05 | K983578 | FDA 510(k) | Class I | Active |
| Bio-Pen Srk Ii Calculator | K922590 | FDA 510(k) | Class III | Active |
| Fluoromatic Gentamicin Fia Immunoassay | K791547 | FDA 510(k) | Class II | Active |
| Liquichek(r) Unassayed Chemistry Contr(human) 1&2 | K914255 | FDA 510(k) | Class I | Active |
| Bio-Rad Total Protein Test Kit | K913315 | FDA 510(k) | Class I | Active |
| Liquichek Hematology-16 Control, Low, Normal And High | K942209 | FDA 510(k) | Class II | Active |
| Quantimune E3 Ria | K802944 | FDA 510(k) | Class I | Active |
| Quantimune Estriol Ria | K811709 | FDA 510(k) | Class I | Active |
| Architect Folate Masterchek, Model # 6c12-05 | K984625 | FDA 510(k) | Class I | Active |
| Lyphochek Routine Urine Controls 1 & 2 (human) | K884424 | FDA 510(k) | Class I | Active |
| Lyphochek Whole Blood Control (human) Levels 1, 2, 3 | K895905 | FDA 510(k) | Class I | Active |
| Liquichek Immunology Control Level 1, 2, 3, 1, Ml, Liquichek Immunology Control Level 1, 3 Ml, Liquichek Immunology Control | K011494 | FDA 510(k) | Class I | Active |