# K010328: Multiple (Izon Dna Blood Collection Kit)

- Pathway: 510(k) (Traditional)
- Applicant: Izon Business Products, Inc.
- Decided: Apr 9, 2001 after 66 days
- Product code: PJE (Blood/Plasma Collection Device For Dna Testing)
- 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
A blood collection kit for DNA is a devioe intended for medical purposes to collect and to handle blood specimens prior to further testing. This type of device may include blood collection tubes, vials, systems, or vacuuin ssmple tubes.

Source page: https://510kreport.com/device/K010328
Methodology: https://510kreport.com/methodology