Device Classification Name |
kit, cell screening, fetal
|
510(k) Number |
BK920025 |
Tradename |
Dade Fetal-Cyte Screening Kit
|
Device Name |
KIT, CELL SCREENING, FETAL |
Original Applicant |
Baxter Healthcare Corporation |
1 baxter pkwy. |
deerfield,
IL
60015
|
|
Classification Product Code |
|
Date Received | 08/28/1992 |
Decision Date | 08/05/1993 |
Decision |
substantially equivalent (SE) |
Review Advisory Committee |
Pathology
|
Type |
510(k) Traditional
|
Total Product Life Cycle (TPLC) |
TPLC Device Report
|
Reviewed by Third Party |
No
|
Expedited Review |
No
|
Combination Product |
No
|
In Vitro Product |
Yes
|
|
|