FDA 510(k) Applications Submitted by James Li

FDA 510(k) Number Submission Date Device Name Applicant
K170864 03/23/2017 VALIDATE D-Dimer Calibration Verification / Linearity Test Kit Maine Standards Company LLC
K162705 09/28/2016 VALIDATE« D-Dimer Calibration Verification/ Linearity Test Kit MAINE STANDARDS COMPANY LLC
K152961 10/07/2015 VALIDATE D-Dimer Calibration Verification/Linearity Test Kit MAINE STANDARDS COMPANY LLC
K142964 10/14/2014 VALIDATE Anemia Calibration Verification/ Linearity Test Kit MAINE STANDARDS COMPANY, LLC
K163498 12/13/2016 VALIDATE Heparin Calibration Verification/Linearity Test Kit MAINE STANDARDS COMPANY, LLC
K980336 01/28/1998 IV STANDS CLINTON INDUSTRIES, INC.
K070500 02/21/2007 BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM, MODEL NICAS 2004 SLIM NI MEDICAL
K080941 04/03/2008 BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM N.I. MEDICAL, LTD.
K061628 06/12/2006 JOSTRA QUADROX D SAFELINE DIFFUSION MEMBRANE OXYGENATOR, MODEL HMOD 2030 MAQUET CARDIOPULMONARY AG
K061832 06/29/2006 JOSTRA HLM TUBING SETS WITH SAFELINE COATING MAQUET CARDIOPULMONARY AG
K220760 03/15/2022 Pre-Formed Penile Silicone Block International Medical Devices, Inc.
K181387 05/25/2018 Pre-Formed Penile Silicone Block International Medical Devices, Inc.
K042380 09/01/2004 SILICONE BLOCK NATIONAL MEDICAL DEVICES, INC.
K162624 09/20/2016 Pre-Formed Penile Silicone Block INTERNATIONAL MEDICAL DEVICES, INC.
K071104 04/19/2007 ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM FLIER'S QUALITY WATER SYSTEMS INC
K231261 05/01/2023 Altaviz Needle Kit II Altaviz, LLC
K222681 09/06/2022 Altaviz Needle Kit Altaviz, LLC
K230549 02/28/2023 IPL Hair Removal Device, Model(s): FY-B505AL, FY-B505AG, FY-B505BL, FY-B505BG, FY-B507AL, FY-B507AG, FY-B507BL, FY-B507BG, FY-B508AL, FY-B508AG, FY-B508BL, FY-B508BG, FY-B509AL, FY-B509AG, FY-B509BL, FY-B509BG Shenzhen Xiazhifeng Electronic Co., Ltd.
K111206 04/29/2011 TECO DIAGNOSTICS SALIVA ALCOHOL TEST TECO DIAGNOSTICS
K232571 08/24/2023 CATHTONGÖ II PICC Catheter L&Z US, Inc.
K232594 08/25/2023 CATHTONGÖ II PICC Catheter L&Z US, Inc.
K152642 09/15/2015 LCCS Disposable RF Electrode, LCCS Reusable RF Electrode LCCS PRODUCTS LIMITED
K230135 01/18/2023 Copioumed Chemotherapy Isolation Gown Copioumed International Inc.
K964696 11/22/1996 SUNSOFT (METHAFILCON A) SOFT (HYDROPHILIC) DAILY WEAR CONTACT LENS SUNSOFT CORP.
K162755 09/30/2016 Picocare WON TECH CO., LTD.
K972538 07/08/1997 FLOW-EZE BLUNT CANNULA (1999BC) ACACIA, INC.
K120152 01/18/2012 CERASORB PLUS RIEMSER ARZNEIMITTEL AG
K110520 02/23/2011 BIOLIS 12I TOKYO BOEKI MEDISYS INC.
K960965 03/11/1996 FRONT LOAD INJECTOR TURRET MODEL 859-0001/200 ML FRONT LOAD SYRINGE MODEL 853-0211 COEUR LABORATORIES, INC.
K961189 03/26/1996 TAS A PTT TEST CONTROLS CARDIOVASCULAR DIAGNOSTICS, INC.
K040958 04/13/2004 PRESTIGE MODELS 24I AND 400 AND MGC MODEL 240 TOKYO BOEKI MEDICAL SYSTEM LTD.
K961814 05/10/1996 THROMBOLYTIC ASSESSMENT SYSTEM PROTHROMBIN TIME TEST CONTROLS CARDIOVASCULAR DIAGNOSTICS, INC.
K971748 05/12/1997 TAS PT-NCTEST CONTROLS CARDIOVASCULAR DIAGNOSTICS, INC.
K113042 10/12/2011 REVOIS IMPLANT SYSTEM RIEMSER ARZNEIMITTEL AG
K113282 11/07/2011 CERASORB DENTAL,CERADORB M DENTAL, CERASORB PERIO RIEMSER ARZEIMITTEL AG
K103531 12/01/2010 PRESTIGE 24I; BIOLIS 24I; MGC 240 TOKYO BOEKI MEDISYS INC.
K965214 12/30/1996 COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002) COEUR LABORATORIES, INC.
K161016 04/11/2016 Z-Clamp ISP System Zavation, LLC
K173752 12/08/2017 SI Screw System Zavation Medical Products, LLC
K112220 08/02/2011 DEVILBISS INTELLIPAP / SLEEPCUBE AUTO BILEVEL DEVILBISS HEALTHCARE LLC
K123127 10/04/2012 VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406 MAINE STANDARDS CO.
K133550 11/19/2013 VALIDATE FERRITIN CALIBRATION VERIFICATION/ LINEARITY TEST KIT MAINE STANDARDS COMPANY LLC


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