Device Classification Name |
Media, Reproductive
|
510(k) Number |
K170681 |
Device Name |
Continuous Single Culture -NX (CSCM-NX) |
Applicant |
Irvine Scientific Sales Co., Inc. |
2511 Daimler Street |
Santa Ana,
CA
92705
|
|
Applicant Contact |
Jayme Yamaguchi-Owens |
Correspondent |
Irvine Scientific Sales Co., Inc. |
2511 Daimler Street |
Santa Ana,
CA
92705
|
|
Correspondent Contact |
Jayme Yamaguchi-Owens |
Regulation Number | 884.6180 |
Classification Product Code |
|
Date Received | 03/06/2017 |
Decision Date | 06/08/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|