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
- K102552HEMOSIL LA POSITIVE CONTROL2Cleared 510(K)
- K100103SPECIALTY ASSAYED CONTROL-22Cleared 510(K)
- K062306PLASMACON N, PLASMACON L-1, PLASMACON L-22Cleared 510(K)
- K061803STA - CONTROL LA 1+22Cleared 510(K)
- K032804CRYOCHECK WEAK LUPUS POSITIVE CONTROL2Cleared 510(K)
- K023312CONTROL PLASMA P2Cleared 510(K)
- K020878LYPHOCHEK HEMOSTASIS, MODELS 798, 7992Cleared 510(K)
- K020109SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL2Cleared 510(K)
- K012422K-ASSAY D-DIMER CONTROLS2Cleared 510(K)
- K003329SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A52172Cleared 510(K)
- K993332GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-05, LALP-1, LALP-052Cleared 510(K)
- K984130COAGULATION CONTROL LEVEL 2 (ABNORMAL)2Cleared 510(K)
- K984131COAGULATION CONTROL LEVEL 3 (ABNORMAL)2Cleared 510(K)
- K961370LA POSITIVE CONTROL PLASMA2Cleared 510(K)
- K955040AT-III CONTROL PLASMA KIT2Cleared 510(K)
- K952623CRYO CHECK LUPUS PLASMA2Cleared 510(K)
- K952624CRYO CHECK ABNORMAL REFERENCE CHECK I & II2Cleared 510(K)
- K945856POSITIVE LUPUS ANTICOAGULANT PLASMA2Cleared 510(K)
- K952338STA-COAG CONTROL [P] PLUS KIT2Cleared 510(K)
- K941872SPECIALTY ASSAYED CONTROL-2 CAT. NO. 53022Cleared 510(K)
- K930267BIOMERIEUX UNIPLASMATROL NORMAL & ABNORMAL2Cleared 510(K)
- K924402CONTROL PLASMA U2Cleared 510(K)
- K924401PATHOPLASMA(R) I & II (PATH CITRATED HUMAN PLASMA)2Cleared 510(K)
- K930959FACTOR CONTROL [P]2Cleared 510(K)
- K930923COAG-CONTROL2Cleared 510(K)
- K924405CONTROL PLASMA P2Cleared 510(K)
- K921665AVK CONTROL I & II2Cleared 510(K)
- K911885DADE(R) PROTEIN C ABNORMAL CONTRAL2Cleared 510(K)
- K904073COAGULATION REFERENCE PLASMA, ABNORMAL2Cleared 510(K)
- K901233ORTHO ABNORMAL PROTEIN C CONTROL PLASMA2Cleared 510(K)
- K900782HEPARIN CONTROL PLASMA, FOR USE IN APTT2Cleared 510(K)
- K895260ABNORMAL COAGULATION CONTROL PLASMA-1 (ACCP-1)2Cleared 510(K)
- K895261ABNORMAL COAGULATION CONTROL PLASMA-2 (ACCP-2)2Cleared 510(K)
- K894425ACS HUMAN PLASMA COAGULATION CONTROL LEVEL III2Cleared 510(K)
- K894338ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL III2Cleared 510(K)
- K893970ACS HUMAN PLASMA COAGULATION CONTROL LEVEL II2Cleared 510(K)
- K893971ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL II2Cleared 510(K)
- K881510CLP ABNORMAL COAGULATION CONTROL2Cleared 510(K)
- K871420HERPES 1 AND 2 MICROASSAYS2Cleared 510(K)
- K770188HPC TM (HEPARINIZED PLASMA CONTROL)2Cleared 510(K)
- 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
- 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
SPECIALTY ASSAYED CONTROL-2 CAT. NO. 5302
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K941872
- 510(k) Type
- Traditional
- Applicant
- HELENA LABORATORIES
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/21/1994
- Days to Decision
- 217 days
- Submission Type
- Statement