FDA 510(k) Applications Submitted by Jayme Yamaguchi-Owens
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K160006 |
01/04/2016 |
Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit Kit-Thaw Oocytes, Embryos and PN zygotes Vitrification Thaw Kit |
Irvine Scientific |
| K190152 |
01/30/2019 |
Vit Kit- Freeze NX and Vit Kit- Warm NX |
FUJIFILM Irvine Scientific, Inc. |
| K170602 |
03/01/2017 |
Continuous Single Culture-NX Complete (CSCM-NXC) |
Irvine Scientific Sales Co., Inc. |
| K170681 |
03/06/2017 |
Continuous Single Culture -NX (CSCM-NX) |
Irvine Scientific Sales Co., Inc. |
| K121128 |
04/13/2012 |
MULTIPURPOSE HANDLING MEDIUM |
IRVINE SCIENTIFIC SALES CO., INC. |
| K171224 |
04/26/2017 |
Arctic Sperm Cryopreservation Medium |
Irvine Scientific Sales Co., Inc. |
| K121572 |
05/29/2012 |
CONTINUOUS SINGLE CULTURE COMPLETE |
IRVINE SCIENTIFIC SALES CO., INC. |
| K093273 |
10/19/2009 |
VIT KIT - FREEZE AND THAW |
IRVINE SCIENTIFIC SALES CO., INC. |
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