# K964960: Vitros Chemistry Products Upro Slides

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Clinical Diagnostics, Inc.
- Decided: Feb 18, 1997 after 69 days
- Product code: JGP (Lowry (Colorimetric), Total Protein)
- Device class: 2
- Regulation: 21 CFR 862.1635
- Recalls of this device: 1 (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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Dec 8, 2016 · Class II · Z-1179-2017: There is a potential for variable negatively and positively biased urine protein results using VITROS UPRO Slides.

Source page: https://510kreport.com/device/K964960
Methodology: https://510kreport.com/methodology