510(k) K973628 ยท JJF Analyzer, Chemistry, Micro, For Clinical Use
VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA
| Applicant | Vital Scientific N.V., Newton MA, US |
| Decision | Substantially Equivalent, Mar 13, 1998 |
| Received | Sep 24, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973628
| 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 | 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.