Device product
Syphilis Test Card Whole Blood(Serum) LumiQuick, Santa Clara, CA 95054
Z-1338-2014
Product summary
- Event
- Event 67665
- Status
- Terminated
- Classification
- Class II
- Quantity
- ALL
- Official record key
device-enforcement:Z-1338-2014
Official wording
Reason: Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
Code information: Catalog number: 71016, All lots
Distribution pattern: Distributed in the states of CA, FL, NJ, TX, and NY.
Derived failure modes
-
Unknown
Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.