# K992244: Greiner Minicollect Coagulation Blood Collection Tube

- Pathway: 510(k) (Traditional)
- Applicant: Greiner Meditech, Inc.
- Decided: Jul 26, 1999 after 24 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
Longest line of descent: 1 generation back to K971221 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971221: Greiner Vacuette Blood Collection Tube, Greiner America, Inc. (1997) Summary page 1.

## Indications for use
The MiniCollect® Coagulation tube is intended for collection of citrate anticoagulated whole blood samples for Coagulation Assays.

Source page: https://510kreport.com/device/K992244
Methodology: https://510kreport.com/methodology