Company ยท US
Vital Scientific N.V.
FDA 510(k) clearances and medical device recalls filed under this name, 1998 to 2002. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
8recalls (0 in 12 months)
7recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 1, 2002 | K022021 | VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT Vital Scientific N.V. | GFO |
| Oct 25, 2002 | K021976 | FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON Vital Scientific N.V. | KQG |
| Jul 23, 2002 | K022046 | VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEVEL 1,2,3,QUIKCOAG COAGULATION CONTROL Vital Scientific N.V. | GGN |
| May 15, 2002 | K020840 | VITAL SCIENTIFIC PT WITH CALCIUM Vital Scientific N.V. | GJS |
| Mar 13, 1998 | K973628 | VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA Vital Scientific N.V. | JJF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 15, 2018 | Vital Scientific N.V. V-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180 Open, Classified |
JJF | K973628 |
| Sep 7, 2018 | Vital Scientific N.V. V-Twin, Catalog # 6002-800, UDI: 03661540600180 - Product Usage: An in vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with cert Terminated |
JJF | None listed |
| Jan 18, 2016 | Vital Scientific N.V. V-Twin, Model # 6002-800, UDI: 03661540600180
Product Usage:
An in-vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain Open, Classified |
JJF | K973628 |
| Jan 10, 2012 | Vital Scientific N.V. Selectra ProS Analyzer, Catalog # 6003-600/UDI # 03661540600418
Product Usage: :clinical chemistry system intended for use in clinical laboratories. Terminated |
JGS | K102647 |
| Jan 10, 2012 | Vital Scientific N.V. Selectra ProM Analyzer, Catalog # 6003-435/UDI # 03661540600395 and Catalog # 6003-436/UDI # 03661540600401
Product Usage: :clinical chemistry system intended for use in clinical laboratories. Terminated |
JGS | K102647 |
| Jan 10, 2012 | Vital Scientific N.V. V-Twin, Catalog # 6002-800, UDI # 03661540600180
Product Usage: automated chemistry analyzer intended for clinical use Terminated |
JJF | K973628 |
| Jan 10, 2012 | Vital Scientific N.V. Viva-E, Catalog # 6002-380, UDI # 03661540600050
Product Usage: automated chemistry analyzer intended for clinical use Terminated |
JJF | K973628 |
| Jan 10, 2012 | Vital Scientific N.V. Viva - JR, catalog # 6002-940, UDI # 03661540600210
Product Usage: automated chemistry analyzer intended for clinical use Terminated |
JJF | K973628 |