Sta - Liatest Vwf Test Kit
510(k) K962675
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK962675 | Date25 Oct 1996 | StatusActive |
Recalls
-
- Terminated Z-0951-2013
Diagnostica Stago has confirmed that sometimes the delta OD measured can be changed leading to a lowered percentage result.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- GJT
- Device Class
- Class II
- Regulation
- 21 CFR Part 864.7290
- Advisory Committee
- Hematology
- FDA Decision
- SESE Substantially Equivalent