FDA 510(k) Applications for Medical Device Product Code "MQK"
(Labware, Assisted Reproduction)

FDA 510(k) Number Applicant Device Name Decision Date
K993881 INTL., INC. GENX CULTURE DISH 02/14/2000
K080395 INTL., INC. SUNIVF DISHES 08/13/2008
K203626 Allwin Medical Devices, Inc SureStrip Vitrification Straw, SureLock Vitrification Straw 06/04/2021
K141663 AUXOGYN, INC. EEVA DISH (WITH 12 MICROWELLS) 07/22/2014
K103028 AUXOGYN, INC. EEVATM PETRI DISH 08/11/2011
K991249 BECTON DICKINSON LABWARE FALCON IVF FOUR WELL PLATE 05/05/1999
K991251 BECTON DICKINSON LABWARE FALCON IVF ONE WELL DISH 05/05/1999
K991253 BECTON DICKINSON LABWARE FALCON IVF ROUND DISH 05/05/1999
K052457 BIOCOAT, INC. PICSI SPERM SELECTION DEVICE 04/13/2006
K081896 BIOGENICS, INC. BIOGENICS BIOQUAD 4-WELL IVF CULTURE DISH 08/20/2008
K122982 BIOTECH, INC. CRYOLOCK 01/09/2014
K221810 Bonraybio Co., LTD. LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device 10/31/2022
K092398 CRYO BIO SYSTEM HSV STRAW 10/06/2010
K173075 DxNow, Inc. ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850╡l, 3ml) 03/08/2018
K994361 GENESIS INDUSTRIES, INC. ESP FOUR WELL TISSUE CULTURE PLATE, ESP SIX WELL TISSUE CULTURE PLATE, ESP MICRO SIX WELL TISSUE CULTURE PLATE, ESP WELL 02/18/2000
K123641 HERTART CULTURE DISH 40 MM, CULTURE DISH 60 MM, MICRO DROPLET CULTURE DISH, 5 WELL CULTURE DISH, CENTRE WELL DISH, ICSI DISH 07/03/2013
K150756 HERTART Micro well group culture dish, 9-well; Micro well group culture dish, 16-well 07/20/2015
K201213 HertART Aps Pasteur Pipette 3mL, Pasteur Pipette 1mL 12/16/2020
K990941 HUMAGEN FERTILITY DIAGNOSTICS, INC. NEWLIFE DISH (ETCHED OR NON-ETCHED, WITH OR WITHOUT LID), MODELS 14-52, 1452E, 1452EL, 1452L 07/14/1999
K000915 HUMAGEN FERTILITY DIAGNOSTICS, INC. PASTEUR PIPET - STERILE 9, PASTEUR PIPET - STERILE 5 3/4, MODELS 16-PP-9, 16-PP-5.75 05/12/2000
K112695 KITAZATO BIOPHARMA CO;LTD CRYOTOP 12/12/2012
K153027 KITAZATO BIOPHARMA CO., LTD. Cryotop US 03/14/2016
K140072 KITAZATO BIOPHARMA CO., LTD. CRYOTOP(R) SC 04/03/2014
K181469 Kitazato Corporation Cryotop«US-flash and Cryotop«US-scoop 11/09/2018
K112644 LOTUS BIO LTD SEAFORIA SPERM SEPARATION ASSISTANCE SYSTEM 12/19/2012
K133295 MENICON CO., LTD. NEW BUSINESS DIVISION QUALIS 06/18/2014
K100596 MID-ATLANTIC DIAGNOSTICS, INC. CRYOPETTE 12/06/2010
K131145 NIDACON INTERNATIONAL AB PROINSERT 02/20/2014
K070047 NUNC A/S NUNC IVF DISHES AND NUNC IVF 4-WELL DISH 05/18/2007
K040717 NUNC A/S NUNC IVF MULTIDISH 4 WELLS NUNCLON 08/12/2004
K162833 ORIGIO A/S VitriGuard 02/16/2017
K180740 ORIGIO a/s VitriGuard 05/04/2018
K200815 ORIGIO a/s VitriGuard 06/25/2020
K162640 REPROBITECH CORP. iVitri EZ 06/30/2017
K172751 Reprobitech Corp. iVitri Straw 02/09/2018
K162051 REPROLIFE INC. Cryotec 12/14/2016
K112413 RESEARCH INSTRUMENTS LTD. RI MSC (MIGRATION SEDIMENTATION CHAMBER) 07/13/2012
K090429 THERMO FISHER SCIENTIFIC (NALGE NUNC INTL) NUNC IVF CENTERWELL AND ICSI DISHES 09/18/2009
K150961 VITROLIFE A/S EmbryoSlide Culture Dish 12/04/2015
K213869 Vitrolife A/S EmbryoSlide+ ic8 dish 03/11/2022
K090832 VITROLIFE SWEDEN AB RAPID-I 12/23/2009
K140207 VITROLIFE SWEDEN AB RAPID-I KIT 12/18/2014
K181461 Vitrolife Sweden AB Rapid-iÖ Kit 01/04/2019


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