VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA— 510(k) K973628
Substantially EquivalentVital Scientific N.V.
FDA 510(k) clearance K973628 for VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA, Substantially Equivalent on 1998-03-13. Applicant: Vital Scientific N.V.. Device class: 1.
Clearance details
- Applicant
- Vital Scientific N.V.
- Product code
- Code JJF
- Device class
- Class 1
- Regulation
- 21 CFR 862.2170
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Newton, MA, US
Recent devices under product code JJF
view allMore clearances from Vital Scientific N.V.
view allRecalls naming K973628
K-number listed on FDA's recall record- Z-0547-2020 — V-Twin, REF 6002-800 or 6002-850, SN 18-3304, IVD, (01)03661540600180
- Z-2558-2019 — 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 materials to measure a variety of analytes, including applications in clinical chemistry, monitoring drugs of abuse and in therapeutic drug monitoring.
- Z-0154-2020 — Viva - JR, catalog # 6002-940, UDI # 03661540600210 Product Usage: automated chemistry analyzer intended for clinical use
- Z-0155-2020 — Viva-E, Catalog # 6002-380, UDI # 03661540600050 Product Usage: automated chemistry analyzer intended for clinical use
- Z-0156-2020 — V-Twin, Catalog # 6002-800, UDI # 03661540600180 Product Usage: automated chemistry analyzer intended for clinical use
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K973628.
Data sourced from openFDA. This site is unofficial and independent of the FDA.