# K873363: Uric Acid Pap

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Oct 19, 1987 after 59 days
- Product code: KNK (Acid, Uric, Uricase (Colorimetric))
- Device class: 1
- Regulation: 21 CFR 862.1775
- 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.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices 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.

## Most influential descendants
- K981766: Uric Acid (1998), 1 descendant of its own
- K102568: Uric Acid Model 3P39 (2011), 0 descendants of its own
- K981189: Uric Acid (1998), 0 descendants of its own

## Recalls of this device
- May 7, 2015 · Class II · Z-1931-2015: Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when the tests are run with urine samples (Creatinine p

Source page: https://510kreport.com/device/K873363
Methodology: https://510kreport.com/methodology