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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: 05/01/2024
 
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Device Name
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Requester
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De Novo
Number
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510(k)
Number
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Decision
Date
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Zuno Smart Sterilization Container Zuno Medical, Inc. DEN210004 06/17/2022
ZINC TRANSPORTER 8 ANTIBODY (ZNT8AB) ELI KRONUS MARKET DEVELOPMENT ASSOCIATES, IN DEN140001 08/20/2014
ZIKV Detect 2.0 IgM Capture ELISA InBios International, Inc. DEN180069 05/23/2019
ZELTIQ AESTHETICS DERMAL COOLING DEVICE ZELTIQ AESTHETICS DEN090002 K080521 08/24/2010
ZAP-IT! ECOBRANDS LTD. DEN100024 11/07/2014
ZANZA-CLICK TECNIMED S.R.L. DEN130019 11/07/2014
XTAG GASTROINTESTINAL PATHOGEN PANEL (GP LUMINEX MOLECULAR DIAGNOSTICS, INC. DEN130003 K121454 01/14/2013
XSTAT REVMEDX, INC. DEN130016 K130218 04/03/2014
X-RAY ATTENUATING CREAM BLOXR CORPORATION DEN120022 K123422 05/09/2013
XPERT MTB/RIF ASSAY CEPHEID DEN130032 K131706 07/25/2013
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