# K842828: Streptex ZL01

- Pathway: 510(k) (Traditional)
- Applicant: Wellcome Diagnostics
- Decided: Aug 15, 1984 after 26 days
- Product code: JTO (Discs, Strips And Reagents, Microorganism Differentiation)
- Device class: 1
- Regulation: 21 CFR 866.2660
- Recalls of this device: 2 (0 Class I)
- 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 has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- May 2, 2013 · Class II · Z-0537-2014: The product may give weak or false negative test results.
- May 2, 2013 · Class II · Z-0538-2014: The product may give weak or false negative test results.

Source page: https://510kreport.com/device/K842828
Methodology: https://510kreport.com/methodology