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
- K152776Glocyte Automated Cell Counter System2Cleared 510(K)
- K091539IQ 200 URINE ANALIZER BODY FLUIDS MODULE2Cleared 510(K)
- K071652HEMOCUE WBC SYSTEM2Cleared 510(K)
- K051693MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM2Cleared 510(K)
- K050235IQ 200 URINE ANALYZER BODY FLUIDS MODULE2Cleared 510(K)
- K032677SYSMEX POCH-100I2Cleared 510(K)
- K022331ADVIA 120 HEMATOLOGY SYSTEM, CEREBROSPINAL FLUID METHOD2Cleared 510(K)
- K001683SYSMEX R-5002Cleared 510(K)
- K991070COULTER Z2 ANALYZER2Cleared 510(K)
- K981950SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-35002Cleared 510(K)
- K981761SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZER2Cleared 510(K)
- K971998ADVIA 120 HEMATOLOGY SYSTEM, IN VITRO DIAGNOSTIC SYSTEM2Cleared 510(K)
- K964375SYSMEX SE/RAM-12Cleared 510(K)
- K962988COULTER GEN-S SYSTEM2Cleared 510(K)
- K954607RETICULOCYTE METHOD2Cleared 510(K)
- K954006YELLOW IRIS URINALYSIS WORKSTATION W/IRISCOPE BODY FLUID ANALYSIS CAPABILITY2Cleared 510(K)
- K952308COULTER Z 12Cleared 510(K)
- K934539THE YELLOW IRIS URINALYSIS WORKSTATION WITH IRISCOPE BODY FLUID ANALYSIS CAPABILITY2Cleared 510(K)
- K930685TECHNICON H* 3TM RTC SYSTEM (IN-VITRO DIAG.SYST.)2Cleared 510(K)
- K923121QBC HEMACAN HEMATOLOGY SYSTEM2Cleared 510(K)
- K920719IVOS ANALYZER2Cleared 510(K)
- K914256YELLOW IRIS URINALYSIS WRKSTA W/IRISCOPE BDY FLU2Cleared 510(K)
- K912494SYSMEX(TM) R-3000 AUTOMATED RETICULOCYTE ANALYZER2Cleared 510(K)
- K911172SYSMEX F-6102Cleared 510(K)
- K911173SYSMEX F-3102Cleared 510(K)
- K910849SYSMEX F-8102Cleared 510(K)
- K910679GENESIS I AUTOMATED CELL COUNTER2Cleared 510(K)
- K894539SYSMEX R-1000 AUTOMATED RETICULOCYTE ANALYZER2Cleared 510(K)
- K885332COULTER FLOW RETICULOCYTE REAGENT2Cleared 510(K)
- K884618NOVA CELLTRAK 11 AUTO. HEMA. ANALYZER, CALIBRATORS2Cleared 510(K)
- K885132FACSMATE SAMPLE HANDLING DEVICE2Cleared 510(K)
- K884471KVM BLOOD CELL COUNTER2Cleared 510(K)
- K880636RETICCOUNT SOFTWARE2Cleared 510(K)
- K874320CELLECT LABTRAK SOFTWARE2Cleared 510(K)
- K872145CELLSOFT(TM)-CASA (SERIES 1000,2000 & 3000)2Cleared 510(K)
- K873271DIGICELL 300 SYSTEM2Cleared 510(K)
- K873252DIGICELL 5002Cleared 510(K)
- K873172HAMILTON-THORN MOTILITY ANALYZER HTM-20002Cleared 510(K)
- K872166FACSCAN FLOW CYTOMETER - RETICCOUNT RETI. ENU. KIT2Cleared 510(K)
- K871830NAPSAC(TM)2Cleared 510(K)
- K873103TECHNICON H*1 JR.(TM) SYSTEM2Cleared 510(K)
- K870603SYSTEM 9000 AUTOMATED CELL COUNTER2Cleared 510(K)
- K863332ATAC 4300 HEMATOLOGY CELL COUNTER2Cleared 510(K)
- K863291IL CELLECT 82Cleared 510(K)
- K863290IL CELLECT 72Cleared 510(K)
- K863085COULTER COUNTER MODEL T-5402Cleared 510(K)
- K863084COULTER COUNTER MODEL T-8902Cleared 510(K)
- K862374CELLECT 8E AUTOMATED BLOOD CELL COUNTERS2Cleared 510(K)
- K861780COULTER COUNTER MODEL S PLUS JUNIOR2Cleared 510(K)
- K860586PHA-2 CONVERSION PROGRAM FOR PLATELET ANALYSIS2Cleared 510(K)
- K860166PICOSCALE BLOOD CELL COUNTER, MODEL PS-52Cleared 510(K)
- K854678ERMA PC-602 PC-603 BLOOD CELL COUNTER2Cleared 510(K)
- K854677ERMA PC-604 BLOOD CELL COUNTER2Cleared 510(K)
- K853030TECHNICON H*1 SYSTEM (HDW)2Cleared 510(K)
- K853722PLT-4 PLATELET ANALYZER2Cleared 510(K)
- K854114COULTER COUNTER MODEL T-6602Cleared 510(K)
- K853036PICOSCALE LABORSCALE, #PSL-1 & ANALYSER, #PSA-12Cleared 510(K)
- K853429COULTER COUNTER MODEL M52Cleared 510(K)
- K851943COULTER VOLUME ADAPTER2Cleared 510(K)
- K851736COULTER CHANNELYZER 2562Cleared 510(K)
- K850171SYSMEX E-3000, FULLY AUTOMATED HEMATOLOGY SYS2Cleared 510(K)
- K850386SYSTEM 8000 CELL COUNTER2Cleared 510(K)
- K845019CELL-DYN 1000 AUTOMATED HEMATOLOGY ANALYZER2Cleared 510(K)
- K841803A1 SYSTEME 8201/22Cleared 510(K)
- K843303COULTER COUNTER MODEL M42Cleared 510(K)
- K843164COULTER COUNTER MODEL ZM2Cleared 510(K)
- K844042BLOOD DILUTION VIAL2Cleared 510(K)
- K842140PICOSCAL BLOOD CELL COUNTER PS-42Cleared 510(K)
- K842346COULTER AUTOMATIC SAMPLE HANDLER2Cleared 510(K)
- K840649DANAM ELEC. SA-10002Cleared 510(K)
- K841504QUICK-COUNT PLUS 22Cleared 510(K)
- K840658QBC CENTRIFUGAL HEMATOLOGY ANALYZ2Cleared 510(K)
- K840170CELL-DYN 100 WHOLE BLOOD PLATELET2Cleared 510(K)
- K834568COULTER COUNTER M22Cleared 510(K)
- K834372PHA-1 PROGRAMMABLE HEMATOLOGY ANALYZ2Cleared 510(K)
- K834026RDW PARAMETER FOR THE TECHNICON H60002Cleared 510(K)
- K833971QUICK-COUNT2Cleared 510(K)
- K832890HEMACOMP 7 OR HEMATIL 72Cleared 510(K)
- K832643CELL-DYN 900 HEMATOLOGY ANALYZER2Cleared 510(K)
- K832627TECHNICON H6000 SYSTEM2Cleared 510(K)
- K832420FACS ANALYZER2Cleared 510(K)
- K832038CELL-DYN 300 HEMATOLOGY ANALYZER2Cleared 510(K)
- K831368CELL-DYN 400 HEMOTOLOGY ANALYZER2Cleared 510(K)
- K830507SYSMEX CC-1702Cleared 510(K)
- K830506SYSMEX CC-1502Cleared 510(K)
- K830505SYSMEX CC-1302Cleared 510(K)
- K830508SYSMEX CC-1802Cleared 510(K)
- K830451QBC CENTRIFUGAL HEMATOLOGY SYS2Cleared 510(K)
- K823886PROFILE 750 BLOOD CELL COUNTER2Cleared 510(K)
- K823344HEMATOLOGY ANALYZER2Cleared 510(K)
- K822758SYSMEX PDA-410 (PARTICLE DISTRIB. ANALY2Cleared 510(K)
- K821575SYSMEX CC-8002Cleared 510(K)
- K821238CC-700 SEVEN PARAMETER, AUTOMATED HEMAA2Cleared 510(K)
- K812031LPC II2Cleared 510(K)
- K811978TECHNICON H6000 (90/HR) HEMATOLOGY SYS2Cleared 510(K)
- K803071PLA-MATE2Cleared 510(K)
- K803218CELL DYN 800 HEMATOLOGY ANALYZER2Cleared 510(K)
- K803128SERIES 810 PLATELET ANALYZER2Cleared 510(K)
- K802636PLATELET COUNTING KIT2Cleared 510(K)
- K802094ORTHO SPECTRUM2Cleared 510(K)
- K802208LEUKOCYTE VOL. ANALYSIS APPARATUS2Cleared 510(K)
- K801545ORTHO AUTOMATED CELL COUNTER2Cleared 510(K)
- K801155TECHNICON H6000 HEMATOLOGY SYSTEM2Cleared 510(K)
- K800346HEMOSAFE2Cleared 510(K)
- K792668COULTER COUNTER-BLOOD CELL COUNTER2Cleared 510(K)
- K792537COULTER COUNTER MODEL S PLUS2Cleared 510(K)
- K791867ROYCO MODEL 921 CELL COUNTER2Cleared 510(K)
- K790026ANALYZER, MODEL CC-7202Cleared 510(K)
- K782101HYCEL COUNTER 2222Cleared 510(K)
- K782102HYCEL COUNTER 2112Cleared 510(K)
- K782100HYCEL COUNTER 3332Cleared 510(K)
- K781562HEMACHECK2Cleared 510(K)
- K781628HEMO-W SYSTEM2Cleared 510(K)
- K781146HEMAC LASER HEMATOLOGY SYSTEM2Cleared 510(K)
- K780909SYSMEX AUTO. BLOOD CELL COUNTER, CC-1202Cleared 510(K)
- K780911SYSMEX PLATELET COUNTER, PL-1102Cleared 510(K)
- K780910SYSTEM AUTO. BLOOD CELL COUNTER CC-1102Cleared 510(K)
- K780224MICROCELL COUNTER MODEL CC-1082Cleared 510(K)
- K771512COUNTER MODEL S PLUS BLOOD CELL COUNTER2Cleared 510(K)
- K771728AUTO. LEUCOCYTE DIFFER. ANALYZER D/902Cleared 510(K)
- K771790DETECTOTERGE AZIDE FREE2Cleared 510(K)
- K771353PLATELET COUNTER & HEMATOCRIT ACCES.2Cleared 510(K)
- K771107COUNTER 700 & HC-700 HEMO 0 REF.2Cleared 510(K)
- K770666HEMALOG 8/902Cleared 510(K)
- K770385LATELET DETERMIN. KIT, CAT NO. 25212Cleared 510(K)
- K761289ULTRA LOGIC 800 HEMATOLOGY ANA. (UL-800)2Cleared 510(K)
- K770034COUNTER, BLOOD CELL & HEMATOCRIT2Cleared 510(K)
- K760765WHOLE BLOOD PLATELET COUNTER -25102Cleared 510(K)
- K760582HA/3 HEMATOLOGY ANALYZER2Cleared 510(K)
- K760581HA/5 HEMATOLOGY ANALYZER2Cleared 510(K)
- 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
- 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
ORTHO SPECTRUM
- Page Type
- Cleared 510(K)
- 510(k) Number
- K802094
- 510(k) Type
- Traditional
- Applicant
- ORTHO INSTRUMENTS
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/10/1980
- Days to Decision
- 38 days