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
- MiscellaneousMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart C—Microbiology DevicesCFR Sub-Part
- Subpart D—Serological ReagentsCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
- KTNSystem, Test, Infectious Mononucleosis2Product Code
- K181436OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test2Cleared 510(K)
- K042272ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA)2Cleared 510(K)
- K030215BIORAPID MONONUCLEOSIS2Cleared 510(K)
- K012901COLOR-MONOGEN2Cleared 510(K)
- K982634DRYSPOT INFECTIOUS MONONUCLEOSIS KIT2Cleared 510(K)
- K981946CLEARVIEW IM2Cleared 510(K)
- K972457MONOCOL/LEX-IM TEST2Cleared 510(K)
- K972231OSOM MONO TEST 1432Cleared 510(K)
- K963425GENZYME DIAGNOSTICS CONTRAST MONO2Cleared 510(K)
- K961024BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB2Cleared 510(K)
- K961550QUALITROL MONO CONTROL SERUM SET2Cleared 510(K)
- K930778IMMUNOCARD MONO2Cleared 510(K)
- K932688EYE SPOT IM TEST2Cleared 510(K)
- K932551ACCUTEX IM LATEX TEST2Cleared 510(K)
- K925183BIOSIGN(TM) MONO-INFECT MONO HETERO ANTIBODY TEST2Cleared 510(K)
- K924037ACCUTEX IM RBC TEST2Cleared 510(K)
- K923767PULSE IM RED CELL TEST2Cleared 510(K)
- K922726TECH SIMPLE INFECTIOUS MONONUCLEOSIS SERUM CONTROL2Cleared 510(K)
- K922296IMFECTIOUS MONONUCLEOSIS IM LIQUID CARD TEST2Cleared 510(K)
- K922297INFECTIOUS MONONUCLEOSIS QIK-DOT IM DRY CARD TEST2Cleared 510(K)
- K920221HEALTHTEST INFECTIOUS MONONUCLEOSIS ASSAY2Cleared 510(K)
- K902510CARDS O.S. MONO2Cleared 510(K)
- K902541MONO-LEX SYSTEM: INFECTIOUS MONONUCLEOSIS LATEX2Cleared 510(K)
- K900625MONO-PLUS POSITIVE AND NEGATIVE CONTROL SET2Cleared 510(K)
- K896926DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS CONTROLS2Cleared 510(K)
- K895891DETECTADOT SYSTEM 2000 HETEROPHILE TEST2Cleared 510(K)
- K895765LEECO PREVIEW(R) EBV (EIA)2Cleared 510(K)
- K894975IMMUNODOT INFECTIOUS MONONUCLEOSIS TEST2Cleared 510(K)
- K894793MONODEX2Cleared 510(K)
- K893737DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS TEST2Cleared 510(K)
- K890991MONO-CUBE(TM)2Cleared 510(K)
- K890041V-TREND TARGET IM TEST2Cleared 510(K)
- K883709MODIFICATION OF MONO-PLUS(TM)2Cleared 510(K)
- K884007CARDS(TM) MONO2Cleared 510(K)
- K883540OXOID INFECTIOUS MONONUCLEOSIS KIT2Cleared 510(K)
- K883004MONO-PLUS(TM)2Cleared 510(K)
- K881247MONO-PHILE2Cleared 510(K)
- K880399V-TREND IM DRY-SPOT TEST2Cleared 510(K)
- K880148INFECTIOUS MONONUCLEOSIS (IM) CARD & LIQUID TEST2Cleared 510(K)
- K874678I.M.N. LATEX2Cleared 510(K)
- K873297DIFFERENTIAL I.M. SCREENING TEST2Cleared 510(K)
- K872032VENTRESCREEN (TM) MONO2Cleared 510(K)
- K864207DISPOSABLE TEST CARDS/GAMMA SLIDE TEST INFECT MONO2Cleared 510(K)
- K862008MONO-LATEX (TM) SLIDE TEST2Cleared 510(K)
- K861452MONOSTAR SYSTEM: IM LATEX TEST2Cleared 510(K)
- K861016GAMMA SLIDE TEST FOR INFECTIOUS MONONUCLEOSIS2Cleared 510(K)
- K853144CARD THREE IM TEST ITEM #2035, CARD ONE IM #20362Cleared 510(K)
- K853105IMMUNO-IM2Cleared 510(K)
- K853388MONOSTICON UNI-DOT2Cleared 510(K)
- K844289SERIES I/S INFECTIONS2Cleared 510(K)
- K841863MONO-TEC2Cleared 510(K)
- K840822LEAP MONO TEST KIT2Cleared 510(K)
- K834345IM-CHECK2Cleared 510(K)
- K830531MONO SCREENING TEST2Cleared 510(K)
- K821386SERO/TEX MONO TEST2Cleared 510(K)
- K812540CORDIA IM2Cleared 510(K)
- K791455AGGLUTINOTEST-INFECTIOUS MONONUCLEOSIS2Cleared 510(K)
- K771397MONOSTICON TEST2Cleared 510(K)
- K760040TEST, MONO., CARD (MACRO-VUE)2Cleared 510(K)
- 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
LEECO PREVIEW(R) EBV (EIA)
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K895765
- 510(k) Type
- Traditional
- Applicant
- LEECO DIAGNOSTICS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/31/1989
- Days to Decision
- 35 days