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- MiscellaneousMiscellaneous
- PQOAnti-Müllerian Hormone Test System2Product Code
- MVOKit, Test, Multiple, Drugs Of Abuse, Over The CounterUProduct Code
- NGMTest, Phencyclidine (Pcp), Over The CounterUProduct Code
- OTWResearch Use Only/Clinical ToxicologyNProduct Code
- PUJVoriconazole Test System2Product 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
- QDRPlazomicin Test System, Immunoassay2Product 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
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B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- DEN220027
- 510(k) Type
- Direct
- Applicant
- BRAHMS GmbH, Part of Thermo Fisher Scientific
- Country
- Germany
- FDA Decision
- Deleted
- Decision Date
- 5/18/2023
- Days to Decision
- 381 days