Vital Scientific N.V.
FDA Regulatory Profile
Vital Scientific N.V. appears in FDA public data with 8 recalls, 5 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0547-2020, Class II) was initiated on November 15, 2018. Its most recent 510(k) clearance was granted on November 1, 2002.
Summary
- Total Recalls
- 8
- 510(k) Clearances
- 5
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0547-2020 | Class II | V-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180 | November 15, 2018 |
| Z-0038-2020 | Class II | V-Twin, Catalog # 6002-800, UDI: 03661540600180 - Product Usage: An in vitro diagnostic device, whic | September 7, 2018 |
| Z-2558-2019 | Class II | V-Twin, Model # 6002-800, UDI: 03661540600180 Product Usage: An in-vitro diagnostic device, whic | January 18, 2016 |
| Z-0158-2020 | Class II | Selectra ProS Analyzer, Catalog # 6003-600/UDI # 03661540600418 Product Usage: :clinical chemist | January 10, 2012 |
| Z-0155-2020 | Class II | Viva-E, Catalog # 6002-380, UDI # 03661540600050 Product Usage: automated chemistry analyzer in | January 10, 2012 |
| Z-0157-2020 | Class II | Selectra ProM Analyzer, Catalog # 6003-435/UDI # 03661540600395 and Catalog # 6003-436/UDI # 0366154 | January 10, 2012 |
| Z-0154-2020 | Class II | Viva - JR, catalog # 6002-940, UDI # 03661540600210 Product Usage: automated chemistry analyz | January 10, 2012 |
| Z-0156-2020 | Class II | V-Twin, Catalog # 6002-800, UDI # 03661540600180 Product Usage: automated chemistry analyzer in | January 10, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K022021 | VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT | November 1, 2002 |
| K021976 | FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON | October 25, 2002 |
| K022046 | VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEVEL 1,2,3,QUIKCOAG COAGULATION CONTROL | July 23, 2002 |
| K020840 | VITAL SCIENTIFIC PT WITH CALCIUM | May 15, 2002 |
| K973628 | VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA | March 13, 1998 |