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- MiscellaneousMiscellaneous
- MVOKit, Test, Multiple, Drugs Of Abuse, Over The CounterUProduct Code
- K040327ACCU-STAT HOME DRUG TESTS FOR MARIJUANA (THC) AND FOR MARIJUANA & COCAINE (THC, COC)UCleared 510(K)
- K030447AT HOME DRUG CUP, MODEL 9150XUCleared 510(K)
- K014192LIFESIGN MET, STATUS STIK MET, ACCUSIGN STIK MET, ACCUSTIK MET, ACCUSIGN MET, STATUS DS METUCleared 510(K)
- K013778PEACE OF MIND HOME DRUG TESTUCleared 510(K)
- K013410AT HOME DRUG TEST, MODEL 9064UCleared 510(K)
- K013412AT HOME DRUG TEST, MODEL 9069UCleared 510(K)
- K013409AT HOME DRUG TEST, MODEL 9074UCleared 510(K)
- K010653AT HOME DRUG TEST, MODEL 9068 TUCleared 510(K)
- K010654AT HOME DRUG TEST, MODEL 9078 TUCleared 510(K)
- K010655AT HOME DRUG TESTT, MODEL 9150 TUCleared 510(K)
Show All 18 Submissions
- NGMTest, Phencyclidine (Pcp), Over The CounterUProduct Code
- OTWResearch Use Only/Clinical ToxicologyNProduct Code
- OXR5-Fluorouracil AssayNProduct Code
- PDBInvestigational Use Only - Clinical ToxicologyNProduct Code
- PGEGastric Emptying Breath Test3Product Code
- PKMChemiluminescent Immunoassay SystemNProduct Code
- PRFDocetaxel / Paclitaxel AssayNProduct Code
- PSSMinoxidil Sulfotransferase Or Isoenzymes Test SystemNProduct Code
- LAOEnzyme Immunoassay, MethotrexateUProduct Code
- LCLRadioimmunoassay, PhencyclidineUProduct Code
- LCMEnzyme Immunoassay, PhencyclidineUProduct Code
- LTDParaquat Assay3Product Code
- MGXTest System, For Drugs Of Abuse3Product Code
- MIGStrip, Test IsoniazidUProduct Code
- MSKImmunoassay For Blood TacrolimusNProduct Code
- PZNPlacental Growth Factor TestNProduct Code
- QBBPlacental Alpha Microglobulin-1 Immunoassay3Product Code
- QWHPrognostic Test For Development Or Progression Of Preeclampsia2Product Code
- QXTInfliximab Test System2Product Code
- QYDAdalimumab Assay2Product Code
- QZHOpioid Use Disorder Genetic Risk Variant Detection System And Collection Kit3Product Code
- Submissions with No Product CodeMiscellaneous
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart D—Clinical Toxicology Test SystemsCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
- Subpart G—Manual Hematology DevicesCFR Sub-Part
- Subpart H—Hematology Kits and PackagesCFR Sub-Part
- Medical GeneticsReview Panel
- UnknownReview Panel
ACCU-STAT HOME DRUG TESTS FOR MARIJUANA (THC) AND FOR MARIJUANA & COCAINE (THC, COC)
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K040327
- 510(k) Type
- Traditional
- Applicant
- Accu-Stat Diagnostics, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/19/2004
- Days to Decision
- 69 days
- Submission Type
- Summary