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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: 05/12/2024
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Download Files | More About De Novo
Device Name
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Requester
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De Novo
Number
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510(k)
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Decision
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NEOGRAM AMINO ACIDS AND ACYLCARNITINES T PERKINELMER LIFE SCIENCES, INC. DEN040002 K031878 08/24/2004
GLUCATELL ASSOCIATES OF CAPE COD, INC. DEN040003 K032373 05/21/2004
CELLERATION MIST THERAPY SYSTEM CELLERATION DEN040004 K032378 06/25/2004
VERICHIP HEALTH INFORMATION MICROTRANSPO DIGITAL ANGEL CORPORATION DEN040007 K033440 10/12/2004
CEDIA SIROLIMUS ASSAY MICROGENICS CORP. DEN040008 K034069 07/28/2004
HAMILTON THORNE ZONA INFRARED LASER OPTI HAMILTON THORNE BIOSCIENCES DEN040009 K040045 11/04/2004
VYSIS AUTOVYSION SYSTEM VYSIS DEN040010 K041875 12/13/2004
AMPLICHIP CYP450 TEST, MODEL 04381866190 ROCHE MOLECULAR SYSTEMS, INC. DEN040011 K042259 12/23/2004
AFFYMETRIX GENECHIP MICROARRAY INSTRUMEN Affymetrix, Inc. DEN040012 K042279 12/23/2004
DECAPINOL ORAL RINSE SINCLAIR PHARMACEUTICALS LIMITED DEN050001 K041482 04/18/2005
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