MQK · Class II · 21 CFR 884.6160

FDA Product Code MQK: Labware, Assisted Reproduction

Leading manufacturers include Kitazato Biopharma Co;Ltd, Becton Dickinson Labware and Origio A/S.

50
Total
50
Cleared
188d
Avg days
1999
Since
50 devices
25–48 of 50
Cleared Jul 22, 2014
EEVA DISH (WITH 12 MICROWELLS)
K141663
Auxogyn, Inc.
Obstetrics & Gynecology · 29d
Cleared Jun 18, 2014
QUALIS
K133295
Menicon Co., Ltd. New Business Division
Obstetrics & Gynecology · 236d
Cleared Apr 03, 2014
CRYOTOP(R) SC
K140072
Kitazato Biopharma Co;Ltd
Obstetrics & Gynecology · 80d
Cleared Feb 20, 2014
PROINSERT
K131145
Nidacon International AB
Obstetrics & Gynecology · 303d
Cleared Jan 09, 2014
CRYOLOCK
K122982
Biotech, Inc.
Obstetrics & Gynecology · 470d
Cleared Jul 03, 2013
CULTURE DISH 40 MM, CULTURE DISH 60 MM, MICRO DROPLET CULTURE DISH, 5 WELL CULTURE DISH, CENTRE WELL DISH, ICSI DISH
K123641
Hertart
Obstetrics & Gynecology · 219d
Cleared Dec 19, 2012
SEAFORIA SPERM SEPARATION ASSISTANCE SYSTEM
K112644
Lotus Bio, Ltd.
Obstetrics & Gynecology · 464d
Cleared Dec 12, 2012
CRYOTOP
K112695
Kitazato Biopharma Co;Ltd
Obstetrics & Gynecology · 454d
Cleared Jul 13, 2012
RI MSC (MIGRATION SEDIMENTATION CHAMBER)
K112413
Research Instruments , Ltd.
Obstetrics & Gynecology · 326d
Cleared Dec 23, 2009
RAPID-I
K090832
Vitrolife Sweden AB
Obstetrics & Gynecology · 272d
Cleared Aug 13, 2008
SUNIVF DISHES
K080395
Intl., Inc.
Obstetrics & Gynecology · 182d
Cleared Feb 18, 2000
ESP FOUR WELL TISSUE CULTURE PLATE, ESP SIX WELL TISSUE CULTURE PLATE, ESP MICRO SIX WELL TISSUE CULTURE PLATE, ESP WELL
K994361
Genesis Industries, Inc.
Obstetrics & Gynecology · 53d
Cleared Feb 14, 2000
GENX CULTURE DISH
K993881
Intl., Inc.
Obstetrics & Gynecology · 90d
Cleared Jul 14, 1999
NEWLIFE DISH (ETCHED OR NON-ETCHED, WITH OR WITHOUT LID), MODELS 14-52, 1452E, 1452EL, 1452L
K990941
Humagen Fertility Diagnostics, Inc.
Obstetrics & Gynecology · 114d
Cleared May 05, 1999
FALCON IVF FOUR WELL PLATE
K991249
Becton Dickinson Labware
Obstetrics & Gynecology · 22d
Cleared May 05, 1999
FALCON IVF ONE WELL DISH
K991251
Becton Dickinson Labware
Obstetrics & Gynecology · 22d
Cleared May 05, 1999
FALCON IVF ROUND DISH
K991253
Becton Dickinson Labware
Obstetrics & Gynecology · 22d