Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cell And Tissue Culture ProductsCFR Sub-Part
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart E—Specimen Preparation ReagentsCFR Sub-Part
- Subpart F—Automated and Semi-Automated Hematology DevicesCFR Sub-Part
- GKFInstrument, Hematocrit, Automated2Product Code
- GKHApparatus, Automated Blood Cell Diluting1Product Code
- GKJSpinner, Slide, Automated1Product Code
- GKLCounter, Cell, Automated (Particle Counter)2Product Code
- GKNTimer, Clot, Automated2Product Code
- GIZPlasma, Control, Normal2Product Code
- GKBDevice, Automated Sedimentation Rate1Product Code
- GGCControl, Plasma, Abnormal2Product Code
- GGNPlasma, Coagulation Control2Product Code
- GHKCentrifuge, Microsedimentation1Product Code
- GHRReagent, Platelet Aggregation2Product Code
- GIEFibrometer2Product Code
- GKPInstrument, Coagulation, Automated2Product Code
- GKRSystem, Hemoglobin, Automated2Product Code
- GKXInstrument, Automated Platelet Counting2Product Code
- GKZCounter, Differential Cell2Product Code
- JBTTimer, Coagulation2Product Code
- JBWRed-Cell Indices, Measured2Product Code
- JOXAnalyzer, Heparin, Automated2Product Code
- JOYDevice, Automated Cell-Locating2Product Code
- JOZSystem, Automated Platelet Aggregation2Product Code
- JPASystem, Multipurpose For In Vitro Coagulation Studies2Product Code
- JPJRed-Cell Indices, Calculated2Product Code
- JWODevice, Blood Volume Measuring2Product Code
- KQGInstrument, Coagulation2Product Code
- KQHRed-Cell Indices2Product Code
- LGPAssay, Alpha-2-Antiplasmin2Product Code
- LKMCounter, Urine Particle2Product Code
- LLGKit, Igg, Platelet Associated2Product Code
- MAMDna-Probe, B And T Lymphocyte2Product Code
- OBW11-Dehydro Thromboxane B2 Kit, Urinary2Product Code
- OYEFlow Cytometric Reagents And Accessories.2Product Code
- PMGAutomated Multicolor Fluorescent Imaging Cytometric Analysis System2Product Code
- POVSemen Analysis Device2Product Code
- K242830LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer2Cleared 510(K)
- K242388LensHooke X12 PRO Semen Analysis System2Cleared 510(K)
- K243114SQA-iOw Sperm Quality Analyzer2Cleared 510(K)
- K241628YO Home Sperm Test2Cleared 510(K)
- K220828SQA-iO Sperm Quality Analyzer2Cleared 510(K)
- K202089LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer2Cleared 510(K)
- K183602SwimCount Sperm Quality Test2Cleared 510(K)
- K180343LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer2Cleared 510(K)
- K172514Trak Plus Male Fertility Testing System2Cleared 510(K)
- K161493YO Home Sperm Test2Cleared 510(K)
- K153683Trak Male Fertility Testing System2Cleared 510(K)
- K100341SPERMCHECK FERTILITY2Cleared 510(K)
- K073039SPERMCHECK VASECTOMY2Cleared 510(K)
- K071737GENERAL SEMEN ANALYSIS KIT2Cleared 510(K)
- K063864QWIKCHECK TEST STRIPS- REAGENT STRIPS FOR SEMEN ANALYSIS2Cleared 510(K)
- K041039FERTELL MALE FERTILITY TEST2Cleared 510(K)
- K032874HBA SPERM-HYALURONAN BINDING ASSAY2Cleared 510(K)
- K024337GENERAL SEMEN ANALYSIS (GSA) KIT2Cleared 510(K)
- K021746SQA V, SPERM QUALITY ANALYZER2Cleared 510(K)
- K012805AUTOMARQER2Cleared 510(K)
- K012352SQA, SPERM QUALITY ANALYZER2Cleared 510(K)
- K011679FERTILMARQ HOME DIAGNOSTIC SCREENING TEST KIT FOR MALE INFERTILITY2Cleared 510(K)
- K990184AUTOMARQER2Cleared 510(K)
- K983473FERTILMARQ TEST KIT2Cleared 510(K)
- K915229SEMEN ANALYSIS KIT2Cleared 510(K)
- K894949SQA2Cleared 510(K)
- K881765CTS-3060 AUTOMATED SEMEN ANALYZER2Cleared 510(K)
- QFRCoagulation System For The Measurement Of Whole Blood Viscoelastic Properties2Product Code
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
- Subpart G—Manual Hematology DevicesCFR Sub-Part
- Subpart G—Tumor Associated Antigen immunological Test SystemsCFR Sub-Part
- Subpart H—Hematology Kits and PackagesCFR Sub-Part
- Subpart I—Hematology ReagentsCFR Sub-Part
- Subpart J—Products Used In Establishments That Manufacture Blood and Blood ProductsCFR Sub-Part
- Subpart K—Products Used In Establishments That Manufacture Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)CFR Sub-Part
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
Trak Male Fertility Testing System
- Page Type
- Cleared 510(K)
- 510(k) Number
- K153683
- 510(k) Type
- Traditional
- Applicant
- SANDSTONE DIAGNOSTICS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/16/2016
- Days to Decision
- 146 days
- Submission Type
- Summary