# K971111: Tri-Tech Inc., Evacuated Blood Collection Tube, Gray Stopper

- Pathway: 510(k) (Traditional)
- Applicant: Tri-Tech, Inc.
- Decided: Jun 16, 1997 after 82 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
plasma or whole blood collection device where glycolytic inhibition of the specimen is required.

Source page: https://510kreport.com/device/K971111
Methodology: https://510kreport.com/methodology