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- 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)
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OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K181436
- 510(k) Type
- Special
- Applicant
- Sekisui Diagnostics, LLC
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/22/2018
- Days to Decision
- 21 days
- Submission Type
- Summary