Medical Device Manufacturer · US , Austin , TX

Kitazato Biopharma Co;Ltd - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2012

Recent clearances: Cryotop Vitrification Kit and Cryotop Thawing Kit, PBS(-), Phosphate Buffered Saline, MINERAL OIL

View 6 510(k) Devices ↓
6
Total
6
Cleared
0
Denied

FDA 510(k) Regulatory Record - Kitazato Biopharma Co;Ltd Obstetrics & Gynecology ✕

6 devices
1-6 of 6
Cleared Oct 07, 2016
Cryotop Vitrification Kit and Cryotop Thawing Kit
K160864 · MQL
Obstetrics & Gynecology · 192d
Cleared Jul 28, 2016
PBS(-), Phosphate Buffered Saline
K160863 · MQL
Obstetrics & Gynecology · 121d
Cleared Apr 21, 2016
MINERAL OIL
K160142 · MQL
Obstetrics & Gynecology · 91d
Cleared Mar 14, 2016
Cryotop US
K153027 · MQK
Obstetrics & Gynecology · 150d
Cleared Apr 03, 2014
CRYOTOP(R) SC
K140072 · MQK
Obstetrics & Gynecology · 80d
Cleared Dec 12, 2012
CRYOTOP
K112695 · MQK
Obstetrics & Gynecology · 454d
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