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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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Decision Date To: 05/24/2024
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Device Name
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De Novo
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510(k)
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VYSIS AUTOVYSION SYSTEM VYSIS DEN040010 K041875 12/13/2004
LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L WAKO CHEMICALS, USA, INC. DEN050002 K041847 05/19/2005
DECAPINOL ORAL RINSE SINCLAIR PHARMACEUTICALS LIMITED DEN050001 K041482 04/18/2005
HAMILTON THORNE ZONA INFRARED LASER OPTI HAMILTON THORNE BIOSCIENCES DEN040009 K040045 11/04/2004
CEDIA SIROLIMUS ASSAY MICROGENICS CORP. DEN040008 K034069 07/28/2004
FACTOR V LEIDEN KIT ROCHE DIAGNOSTICS CORP. DEN030005 K033607 12/17/2003
VERICHIP HEALTH INFORMATION MICROTRANSPO DIGITAL ANGEL CORPORATION DEN040007 K033440 10/12/2004
CELLERATION MIST THERAPY SYSTEM CELLERATION DEN040004 K032378 06/25/2004
GLUCATELL ASSOCIATES OF CAPE COD, INC. DEN040003 K032373 05/21/2004
NEOGRAM AMINO ACIDS AND ACYLCARNITINES T PERKINELMER LIFE SCIENCES, INC. DEN040002 K031878 08/24/2004
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