KSKClass II
Solution, Stabilized Enzyme
Hematology · 21 CFR 864.9400
MDR events3All time
Recalls0All time
Registered firms13Currently listed
510(k) clearances5All time
Recent MDR events
3 adverse event reports on file
Event type breakdown
Malfunction3
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
13 firms currently registered for this product code
Trinity Biotech, Plc
BRAY Wicklow, IE
Immucor, Inc.
Norcross, GA, US
Bio-rad Medical Diagnostics Gmbh
DREIEICH Hesse, DE
Diagast
LOOS Hauts-de-France, FR
Alba Bioscience Limited
PENICUIK Midlothian, GB
Hemo Bioscience
Durham, NC, US
Bio-rad Medical Laboratories Logistik Gmbh
Grosskugel /Kabelsketal Saxony-Anhalt, DE
Diamed Gmbh
Cressier Fribourg, CH
510(k) clearances
5 clearances for this product code
- Gamma Biologicals, Inc.Mar 4, 1982
K813342 · GAMMA CHLOROQUINE DIPHOSPHATE SOLUTION
- Biological Corp. of AmericaFeb 10, 1982
K813404 · FREEZE DRIED FICIN
- Biological Corp. of AmericaJul 21, 1981
K810803 · FREEZE DRIED PAPAIN
- Hyland Therapeutic Div., Travenol LaboratoriesJul 27, 1978
K780962 · AUTOMATED ENZYME
- Bd Becton Dickinson Vacutainer Systems PreanalyticJul 20, 1976
K760123 · AUTOZYME