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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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81 to 90 of 416 results
Decision Date To: 05/29/2024
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Device Name
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De Novo
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510(k)
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Decision
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XTAG GASTROINTESTINAL PATHOGEN PANEL (GP LUMINEX MOLECULAR DIAGNOSTICS, INC. DEN130003 K121454 01/14/2013
FERRISCAN R2-MRI ANALYSIS SYSTEM RESONANCE HEALTH ANALYSIS SERVICES PTY L DEN130012 K124065 01/23/2013
X-RAY ATTENUATING CREAM BLOXR CORPORATION DEN120022 K123422 05/09/2013
TINA-QUANT HBA1C GEN. 2 TEST SYSTEM Roche Diagnostics DEN130002 K121291 05/23/2013
CABOCHON SYSTEM CABOCHON AESTHETICS, INC. DEN110004 K101231 07/12/2013
VERIFY CRONOS SELF-CONTAINED BIOLOGICAL STERIS Corporation DEN110006 K102469 07/12/2013
NEBA SYSTEM LEXICOR MEDICAL TECHNOLOGY, LLC DEN110019 K112711 07/15/2013
XPERT MTB/RIF ASSAY CEPHEID DEN130032 K131706 07/25/2013
VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN ABBOTT MOLECULAR, INC. DEN130010 K123951 07/29/2013
QUANTITATION OF ORGANOPHOSPHATE METABOL CENTERS FOR DISEASE CONTROL AND PREVENTI DEN130005 K122282 08/08/2013
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