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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: 06/08/2024
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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
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XTAG GASTROINTESTINAL PATHOGEN PANEL (GP LUMINEX MOLECULAR DIAGNOSTICS, INC. DEN130003 K121454 01/14/2013
Lumenis Stellar M22 Lumenis Ltd. DEN200028 02/23/2021
PrimeStore MTM Longhorn Vaccines and Diagnostics LLC DEN170029 03/19/2018
LZI Carisoprodol Metabolite (Meprobamate Lin-Zhi International, Inc. DEN170010 04/20/2018
DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM) LIFE TECHNOLOGIES, INC. DEN000008 K001447 02/16/2001
Companion LGCH, INC DEN140033 02/16/2017
NEBA SYSTEM LEXICOR MEDICAL TECHNOLOGY, LLC DEN110019 K112711 07/15/2013
Magnetic Surgical System Levita Magnetics International Corp. DEN150007 06/13/2016
Simple 2 Test LetsGetChecked Inc. (formerly PrivaPath DEN200070 11/15/2023
Leica FL400 Leica Microsystems (Schweiz) AG DEN180024 03/28/2019
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