Vital Scientific N.V.

FDA Regulatory Profile

Summary

Total Recalls
8
510(k) Clearances
5
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0547-2020Class IIV-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180November 15, 2018
Z-0038-2020Class IIV-Twin, Catalog # 6002-800, UDI: 03661540600180 - Product Usage: An in vitro diagnostic device, whicSeptember 7, 2018
Z-2558-2019Class IIV-Twin, Model # 6002-800, UDI: 03661540600180 Product Usage: An in-vitro diagnostic device, whicJanuary 18, 2016
Z-0154-2020Class IIViva - JR, catalog # 6002-940, UDI # 03661540600210 Product Usage: automated chemistry analyzJanuary 10, 2012
Z-0156-2020Class IIV-Twin, Catalog # 6002-800, UDI # 03661540600180 Product Usage: automated chemistry analyzer inJanuary 10, 2012
Z-0157-2020Class IISelectra ProM Analyzer, Catalog # 6003-435/UDI # 03661540600395 and Catalog # 6003-436/UDI # 0366154January 10, 2012
Z-0155-2020Class IIViva-E, Catalog # 6002-380, UDI # 03661540600050 Product Usage: automated chemistry analyzer inJanuary 10, 2012
Z-0158-2020Class IISelectra ProS Analyzer, Catalog # 6003-600/UDI # 03661540600418 Product Usage: :clinical chemistJanuary 10, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K022021VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTTNovember 1, 2002
K021976FIBRON-1, FIBRON-4, QUIKCOAG, FIBRONOctober 25, 2002
K022046VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEVEL 1,2,3,QUIKCOAG COAGULATION CONTROLJuly 23, 2002
K020840VITAL SCIENTIFIC PT WITH CALCIUMMay 15, 2002
K973628VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVAMarch 13, 1998