# K023971: Vacuette Trace Elements Tubes

- Pathway: 510(k) (Traditional)
- Applicant: Greiner Bio-One Vacuette North America
- Decided: Jan 27, 2003 after 59 days
- Product code: JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection)
- Device class: 2
- Regulation: 21 CFR 862.1675
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Becton Dickinson Vacutainer Trace Elements tube with sodium heparin: named in the summary without a submission number

## Indications for use
Greiner VACUETTEB Trace Elements Evacuated Blood Collection Tubes with sodium heparin or no additive are used to collect, transport and process blood for testing plasma, serum, or whole blood for trace elements in the clinical laboratory.

Source page: https://510kreport.com/device/K023971
Methodology: https://510kreport.com/methodology