| Digilab Modular One-Applanation Tonometer | K863217 | FDA 510(k) | Class II | Active |
| Hemoglobin A1c By Column Test (micro A1c) | K862371 | FDA 510(k) | Class II | Active |
| Liquichek Immunoassay Plus Control, Model 360, 361, 362, 363 | K001373 | FDA 510(k) | Class I | Active |
| Abbott Liquid Pediatric Chemistry Control, Model # 4e37-01, 4e38-01 | K990149 | FDA 510(k) | Class I | Active |
| Lyphochek Unassayed Chem. Control (human) I And Ii | K882486 | FDA 510(k) | Class I | Active |
| Lyphochek Coagulation Control Level 1, Lyphochek Coagulation Level 2, Lyphochek Coagulation Level 3, Models 781, 782, 783 | K012722 | FDA 510(k) | Class II | Active |
| Architect Free T4 Mastercheck, List No. 6c50-05 | K984070 | FDA 510(k) | Class I | Active |
| Liquichek Urine Toxicology Control Level S1 Low Opiate & S2 Low Opiate Models 466 & 467 | K021414 | FDA 510(k) | Class I | Active |
| Vreselect Culture Medium | K122187 | FDA 510(k) | Class II | Active |
| Radias Neonatal Tsh Enzyme Immunoassay | K935399 | FDA 510(k) | Class II | Active |
| Liquichek Anti-Ss-A Control, Eia, Model 209 | K984470 | FDA 510(k) | Class II | Active |
| Liquichek Urine Toxicology Control, (levels S1s And S2s) | K042865 | FDA 510(k) | Class I | Active |
| Lyphochek Tumor Marker Control, Levels 1 And 2, 2ml, Model 580 | K011579 | FDA 510(k) | Class I | Active |
| Liquichek Elevated Crp Control | K042837 | FDA 510(k) | Class I | Active |
| Quantimune Ferritin Irma | K810799 | FDA 510(k) | Class II | Active |
| Echoclonal Hcg Irma | K852201 | FDA 510(k) | Class II | Active |
| Lyphochek Drug Free Serum(human) | K852414 | FDA 510(k) | Class I | Active |
| Liquichek Urine Toxicology Control Level C1, Liquichek Urine Toxicology Control Level C2, Liquichek Urine Toxicology Con | K981590 | FDA 510(k) | Class I | Active |
| Lyphochek Unassayed Chemistry Control Level 3 | K922046 | FDA 510(k) | Class I | Active |
| Lyphochek(r) Hemoglobin A2 Control | K911347 | FDA 510(k) | Class II | Active |
| Quantimune Hfsh Ria | K791836 | FDA 510(k) | Class I | Active |
| Abbott Liquid Ammonia Control, Model #'s 1e93-01, 1e94-01, 1e95-01 | K990162 | FDA 510(k) | Class I | Active |
| Liquichek Ana Control, Homogeneous Pattern, Model 201 | K984398 | FDA 510(k) | Class II | Active |
| Radias Monoclonal Hba 1c Assay | K935613 | FDA 510(k) | Class II | Active |
| Bio-Rad Microplate 17-Hydroxyprogesterone Test | K973350 | FDA 510(k) | Class I | Active |
| Radias Phenylalanine Test | K960437 | FDA 510(k) | Class II | Active |
| Liquichek Anti-Rnp Control, Positive, Catalog #116 | K024223 | FDA 510(k) | Class II | Active |
| Radias B12 Enzyme Immunoassay | K933315 | FDA 510(k) | Class II | Active |
| Liquichek Tdm Control | K012741 | FDA 510(k) | Class I | Active |
| Liquichek Routine Urime Chemistry Control, Levels 1 & 2 | K934357 | FDA 510(k) | Class I | Active |
| Variant Beta-Thalassemia Short Program | K924122 | FDA 510(k) | Class II | Active |
| Liquichek Urine Toxicology Control - Level S1, S2, S3 | K971691 | FDA 510(k) | Class I | Active |
| Liquichek Cardiac Markers Control (cat. No. 685, 686, 687, 688) | K961828 | FDA 510(k) | Class I | Active |
| Liquid Assayed Multiqual Control Level1 #981600; Level 2 #981700; Level 3 #981800 | K011867 | FDA 510(k) | Class I | Active |
| Abbott Immunoassay-Mcc (liquid) Control, Model Number 6e20-10 | K990017 | FDA 510(k) | Class I | Active |
| Cotube Hcg Irma Test | K882155 | FDA 510(k) | Class II | Active |
| Liquichek Ena Control, Eia Screen, Model No. 206 | K984462 | FDA 510(k) | Class II | Active |
| Lyphochek Hypertension Markers Control (cat. No. 600) | K971952 | FDA 510(k) | Class I | Active |
| Lyphochek Coagulation Control, Level 4, Model 743 | K032611 | FDA 510(k) | Class II | Active |
| Variant Total Ghb Program | K941616 | FDA 510(k) | Class II | Active |
| Echoclonal Htsh Irma | K860288 | FDA 510(k) | Class II | Active |
| Determin Hemoglobin Alc/Hi Perf Liq Chromatography | K882222 | FDA 510(k) | Class II | Active |
| Benzodiazepines By Remedi Hs | K955116 | FDA 510(k) | Class II | Active |
| Liquichek Ethanol/Ammonia Control | K955024 | FDA 510(k) | Class I | Active |
| Bio-Rad Cyclosporine By Hplc Test | P880032 | FDA PMA | Class II | Active |