Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
- Subpart C—Cell And Tissue Culture ProductsCFR Sub-Part
- KIPFormulations, Balanced Salt Solutions1Product Code
- KIQKit, Culture, Chromosome1Product Code
- KIRCells, Animal And Human, Cultured1Product Code
- K973209FRESH CELLS VERO1Cleared 510(K)
- K973214FRESH CELLS HFF1Cleared 510(K)
- K973213FRESH CELLS LLC-MK21Cleared 510(K)
- K973212FRESH CELLS WI-381Cleared 510(K)
- K973211FRESH CELLS MV1LU1Cleared 510(K)
- K973210FRESH CELLS NCI H2921Cleared 510(K)
- K971508RHMK II CELL CULTURE, AN EXPANDED PRIMARY RHESUS MONKEY KIDNEY CELL CULTURE1Cleared 510(K)
- K972414FRESHCELLS1Cleared 510(K)
- K965047MINK LUNG CELL CULTURE1Cleared 510(K)
- K962780FRESHCELLS, HEP-21Cleared 510(K)
- K962780FRESHCELLS, HEP-21Cleared 510(K)
- K962311FRESHFROZENCELLS1Cleared 510(K)
- K962306FRESH CELLS MULTI-WELL & SHELL VIAL CULTURES1Cleared 510(K)
- K955608MCCOY CELL CULTURES1Cleared 510(K)
- K960909H292 CELL CULTURE1Cleared 510(K)
- K951461NCI-H292 CELL CULTURE1Cleared 510(K)
- K951440LLC-MK2 (MONKEY KIDNEY, MACACA MULATA) CELL CULTURE1Cleared 510(K)
- K955921A549 CELL CULTURE1Cleared 510(K)
- K952727MRC-5 CELL CULTURE VIAL1Cleared 510(K)
- K942820H2921Cleared 510(K)
- K943890WI38 CELL CULTURE1Cleared 510(K)
- K943889VERO CELL CULTURE1Cleared 510(K)
- K943888MDCK CELL CULTURE1Cleared 510(K)
- K943887HUMAN NEWBORN FORESKIN CELL CULTURE1Cleared 510(K)
- K943886BGM CELL CULTURE1Cleared 510(K)
- K943885PRIMARY RABBIT KIDNEY CELL CULTURE1Cleared 510(K)
- K943884PRIMARY MONKEY KIDNEY CELL CULTURE1Cleared 510(K)
- K943891RD CULTURE CELL1Cleared 510(K)
- K936271FRESH CELLS MULTI-WELL PLATE CULTURES AND SHELL VIAL CULTURE1Cleared 510(K)
- K940502FRESH FROZEN CELLS1Cleared 510(K)
- K933927HEP-2 CULTURE CELL1Cleared 510(K)
- K933923A549 CULTURE CELL1Cleared 510(K)
- K933924MCCOY CULTURE CELL1Cleared 510(K)
- K933925MRC-5 CULTURE CELL1Cleared 510(K)
- K933926LLCMK2 CULTURE CELLS1Cleared 510(K)
- K936171TRANSFORMED PRIMARY HUMAN EMBRYONAL KIDNEY1Cleared 510(K)
- K936169RHESUS MONKEY KIDNEY CELLS1Cleared 510(K)
- K936172RHESUS MONKEY KIDNEY CELLS (LLC-MK2)1Cleared 510(K)
- K934973HELA-229/HELA CELLS1Cleared 510(K)
- K934934RABBIT KIDNEY CELLS - R.K.C.1Cleared 510(K)
- K935766PRIMARY AFRICAN GREEN MONKEY KIDNEY CELLS1Cleared 510(K)
- K935336CYNOMOLOGUS MONKEY KIDNEY CELLS1Cleared 510(K)
- K935337RHABDOMYOSARCOMA CELLS1Cleared 510(K)
- K935338LUNG CACINOMA, HUMAN CELLS1Cleared 510(K)
- K935339HELA HELA EPITHELOID CARCINOMA1Cleared 510(K)
- K934245HUMAN FORESKIN FIBROBLAST CELLS-H.F.F.1Cleared 510(K)
- K934246LUNG DIPLOID HUMAN CELLS-WI-381Cleared 510(K)
- K934241MCCOY CULTURE CELLS-MCCOY1Cleared 510(K)
- K934240KIDNEY AFRICIAN GREEN MONKEY CELLS-VERO1Cleared 510(K)
- K934239KIDNEY AFRICAN GREEN MONKEY CELLS-CV-11Cleared 510(K)
- K934242BUFFALO GREEN MONKEY KIDNEY CELLS-B.G.M.K.1Cleared 510(K)
- K934243HUMAN EPIDERMAL CARCINOMA LARYNX CELLS-HEP-21Cleared 510(K)
- K934244HUMAN LUNG DIPLOID CELLS-MRC-51Cleared 510(K)
- K930395ONE DRAM SHELL VIAL, CATALOG #02-4611Cleared 510(K)
- K93039425 CM2, 75 CM2, A50 CM2 FLASK, CATALOG #03-2111Cleared 510(K)
- K930393ONE DRAM SHELL VIAL, CATALOG #02-2611Cleared 510(K)
- K93039716 X 125 MM TEST TUBE, CATALOG1Cleared 510(K)
- K93039125 CM2, 75 CM2, 150 CM2 FLASK, CATALOG #03-2611Cleared 510(K)
- K93039025 CM2, 75 CM2, 125 CM2 FLASK, CATALOG #03-2911Cleared 510(K)
- K93039816 X 125 MM TEST TUBE, CATALOG #01-4411Cleared 510(K)
- K93039216 X 125 MM TEST TUBE, CATALOG #01-1111Cleared 510(K)
- K93039616 X 125 MM TEST TUBE, CATALOG #01-2911Cleared 510(K)
- K930368ONE DRAM SHELL VIAL, CATALOG #02-3211Cleared 510(K)
- K93036725CM2. 75CM2, 150 CM, FLASK, CATALOG #03-3211Cleared 510(K)
- K93036616 X 25 MM TEST TUBE, CATALOG #01-4611Cleared 510(K)
- K93036525CM2, 75CM2, 150CM2 FLASK, CATALOG #03-2411Cleared 510(K)
- K930364ONE DRAM SHELL VIAL, CATALOG # 02-2411Cleared 510(K)
- K930389ONE DRAM SHELL VIAL, CATALOG #02-2911Cleared 510(K)
- K93038816 X 125 MM TEST TUBE, CATALOG #01-2411Cleared 510(K)
- K930387ONE DRAM SHELL VIAL, CATALOG #02-4011Cleared 510(K)
- K93038616 X 125 MM TEST TUBE, CATALOG #01-4011Cleared 510(K)
- K93038516 X 125 MM TEST TUBE, CATALOG #01-4211Cleared 510(K)
- K93038425 CM2, 75 CM2, 150 CM2 FLASK, CATALOG #03-4011Cleared 510(K)
- K93038325 CM2, 75 CM2, 150 CM2 FLASK, CATALOG #03-4211Cleared 510(K)
- K930382ONE DRAMSHELL VIAL, CATALOG #02-4211Cleared 510(K)
- K930381ONE DRAM SHELL VIAL, CATALOG #02-4411Cleared 510(K)
- K93038016 X 125 MM TEST TUBE, CATALOG #01-2611Cleared 510(K)
- K930379ONE DRAM SHELL VIAL, CATALOG #02-2811Cleared 510(K)
- K93037825 CM2, 75 CM2, 150 CM2 FLASK, CATALOG #03-4411Cleared 510(K)
- K93037725 CM2, 75 CM2, 150 CM2 FLASK, CATALOG #03-4611Cleared 510(K)
- K930376ONE DRAM SHELL VIAL, CATALOG #02-2111Cleared 510(K)
- K93037516 X 125 MM TEST TUBE, CATALOG #01-2111Cleared 510(K)
- K93037425 CM2, 75 CM2, 150 CM2, FLASK, CATALOG #03-1111Cleared 510(K)
- K930373ONE DRAM SHELL VIAL, CATALOG #02-1111Cleared 510(K)
- K93037216 X 125 MM TEST TUBE, CATALOG #01-3111Cleared 510(K)
- K93037116 X 125 MM TEST TUBE, CATALOG #01-3211Cleared 510(K)
- K930370ONE DRAM SHELL VIALS, CATALOG #02-3111Cleared 510(K)
- K93036925CM, 75CM, 150CM, FLASK, CATALOG #03-3111Cleared 510(K)
- K930325CYTOQUANT(TM) MDCK CANINE KIDNEY CELLS1Cleared 510(K)
- K924618CYTOQUANT HEP-2 CELLS 25CM/75CM/175CM FLASK#03-2511Cleared 510(K)
- K924595CYTOQUANT HNFS CELLS1Cleared 510(K)
- K924612CYTOQUANT MCCOY CELLS/ONE DRAM SHELL VIAL #02-3011Cleared 510(K)
- K924613CYTOQUANT MCCOY CELLS 25CM2/75CM2 FLASK/#03-3011Cleared 510(K)
- K924614CYTOQUANT H292 HUMAN PULM MUCOEPIDER CARCIN CELLS1Cleared 510(K)
- K924615CYTOQUANT H292 CELLS 25CM2/75CM2/175CM2 FLASK1Cleared 510(K)
- K924616CYTOQUANT HEP-2 CELLS, CATALOG #02-2511Cleared 510(K)
- K924617CYTOQUANT HEP-2 CELLS 16 X 125 MM TUBE, #01-2511Cleared 510(K)
- K924619CYTOQUANT MRC-5 CELLS 16 X 125 MM TUBE, #01-1011Cleared 510(K)
- K924620CYTOQUANT MRC-5 CELLS, CATALOG #03-1011Cleared 510(K)
- K924621CYTOQUANT MRC-5 CELLS, CATALOG #02-1011Cleared 510(K)
- K924622CYTOQUANT A-549 CELLS, CATALOG #02-2011Cleared 510(K)
- K924623CYTOQUANT A-549 CELLS, CATALOG #03-2011Cleared 510(K)
- K924624CYTOQUANT A-549 CELLS, 16X125 MM TUBE #01-2011Cleared 510(K)
- K924625CYTOQUANT HLNFS CELLS, CATLOG #03-1511Cleared 510(K)
- K902726BARTELS EXTRACELLULAR MATRIX1Cleared 510(K)
- K896846MADIN-DARBY CANINE KIDNEY CULTURE CELLS1Cleared 510(K)
- K871613BUFFALO GREEN MONKEY KIDNEY CELLS1Cleared 510(K)
- K871033RABBIT KIDNEY CULTURE CELLS (FIRST PASS)1Cleared 510(K)
- K864776A549 (HUMAN LUNG CARCINOMA) CULTURE CELLS1Cleared 510(K)
- K862555HUMAN EPITHELOID CERVIX CARCINOMA CELLS (HELA)1Cleared 510(K)
- K861585ULTRACLONE 01-2300 CELL LINE1Cleared 510(K)
- K861569ULTRACLONE 01-700 CELL LINE1Cleared 510(K)
- K861373HUMAN LUNG CARCINOMA CELLS (A549)1Cleared 510(K)
- K860292CELLMATIC CHLAMYDIA CULTURE CONFIRM-DIFCO-10001Cleared 510(K)
- K860293CELLMATIC CHLAMYDIA CULTURE CONFIRM-MCCOY CELLS1Cleared 510(K)
- K853203ULTRACLONE ECL-01-2200 CELL LINE1Cleared 510(K)
- K852396HEK1Cleared 510(K)
- K852395MINK LUNG1Cleared 510(K)
- K852394MDCK1Cleared 510(K)
- K852205RMK GENCELLS CULTURE SYSTEM1Cleared 510(K)
- K852206HEP-2 GENCELLS1Cleared 510(K)
- K852204MCCOY GENCELLS1Cleared 510(K)
- K851928HEK GENCELLS1Cleared 510(K)
- K851927VERO GENCELLS1Cleared 510(K)
- K851561WI-38 GENCELLS1Cleared 510(K)
- K851563RK GENCELLS1Cleared 510(K)
- K851562MRC-5 GENCELLS1Cleared 510(K)
- K851545ULTRACLONE ECL-01-800 CELL LINE1Cleared 510(K)
- K840366CELL-MATICS HERPES SIMPLEX VIRUS DETECT1Cleared 510(K)
- K843578ULTRACLONE ECL-01-2100 CELL LINE1Cleared 510(K)
- K843579ULTRACLONE ECL-01-11001Cleared 510(K)
- K843577ULTRAXLONE ECL-01-1000 CELL LINE1Cleared 510(K)
- K843252AFRICAN GREEN SV 5/SV 401Cleared 510(K)
- K843250BHK-211Cleared 510(K)
- K843251RD CELLS1Cleared 510(K)
- K842583SIRC1Cleared 510(K)
- K842584HEK1Cleared 510(K)
- K841998IMR-90-DIPLOID-HUMAN FETAL LUNG CELL1Cleared 510(K)
- K841999BGM CELL CULTURE AFRICAN GREEN MONKEY1Cleared 510(K)
- K842000PRIMARY RABBITT KIDNEY CELL CULTURE1Cleared 510(K)
- K841806WI-381Cleared 510(K)
- K841337ULTRACLONE ECL-01-800 CELL LINE1Cleared 510(K)
- K841340ULTRACLONE ECL-01-900 CELL LINE1Cleared 510(K)
- K841341ULTRACLONE ECL-01-1000 CELL LINE1Cleared 510(K)
- K841342ULTRACLONE ECL-01-400 CELL LINE1Cleared 510(K)
- K841343ULTRACLONE ECL-01-100 CELL LINE1Cleared 510(K)
- K841344ULTRACLONE ECL-01-300 CELL LINE1Cleared 510(K)
- K841345ULTRACLONE ECL-01-500 CELL LINE1Cleared 510(K)
- K841346ULTRACLONE ECL-01-200 CELL LINE1Cleared 510(K)
- K841339ULTRA CLONE ECL-01-700 CELL LINE1Cleared 510(K)
- K841338ULTRACLONE ECL-01-600 CELL LINE1Cleared 510(K)
- K841665RHESUS SV5/SV401Cleared 510(K)
- K841666RABBIT KIDNEY CELLS1Cleared 510(K)
- K834123WI-38 HUMAN LUNG CELLS1Cleared 510(K)
- K834126MRC-5 CELLS1Cleared 510(K)
- K834124VERO CELLS1Cleared 510(K)
- K834120LLC-MK2-RHESUS MONKEY KIDNEY CELLS1Cleared 510(K)
- K834119MCCOY CELLS1Cleared 510(K)
- K834117HUMAN FIBROBLASTIC CELLS-HUMAN NEWBORN1Cleared 510(K)
- K833360HEP-2 CELLS1Cleared 510(K)
- K833358MRC-5 CELLS1Cleared 510(K)
- K833359WI-38 CELLS1Cleared 510(K)
- K832947ORTHO CELL CULTURES-MRC-5 HUMAN EMBRYO1Cleared 510(K)
- K831679MRC-5 CELLS1Cleared 510(K)
- K831684CYNOMOLGUS MONKEY KIDNEY CELLS SV51Cleared 510(K)
- K831683SF CELLS1Cleared 510(K)
- K831680VERO CELLS1Cleared 510(K)
- K831681HEP-2 CELLS1Cleared 510(K)
- K831682MCCOY CELLS1Cleared 510(K)
- K780869CELL CULTURE LINES1Cleared 510(K)
- KISSera, Animal And Human1Product Code
- KITMedia And Components, Synthetic Cell And Tissue Culture1Product Code
- KIWKit, Mycoplasma Detection1Product Code
- KIXMedia, Mycoplasma Detection1Product Code
- KIYChamber, Slide Culture1Product Code
- KIZDish, Tissue Culture1Product Code
- KJAFlask, Tissue Culture1Product Code
- KJBApparatus, Roller1Product Code
- KJCBottle, Roller, Tissue Culture1Product Code
- KJDSpinner, Flask1Product Code
- KJESpinner System, Cell Culture1Product Code
- KJFSystem, Suspension, Cell Culture1Product Code
- KJHApparatus, Perfusion1Product Code
- KPBMedia And Components, Mycoplasma Detection1Product Code
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- Subpart E—Immunology Laboratory Equipment and ReagentsCFR Sub-Part
- Subpart E—Specimen Preparation ReagentsCFR Sub-Part
- Subpart F—Automated and Semi-Automated Hematology DevicesCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
- Subpart G—Tumor Associated Antigen immunological Test SystemsCFR Sub-Part
- Subpart H—Hematology Kits and PackagesCFR Sub-Part
- Subpart J—Products Used In Establishments That Manufacture Blood and Blood ProductsCFR Sub-Part
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
HEP-2 GENCELLS
- Page Type
- Cleared 510(K)
- 510(k) Number
- K852206
- 510(k) Type
- Traditional
- Applicant
- GENUS DIAGNOSTICS
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/4/1985
- Days to Decision
- 14 days