# K864082: Reflotron (R) Alt (GPT)

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Dec 4, 1986 after 45 days
- Product code: CKD (Hydrazone Colorimetry, Alt/Sgpt)
- Device class: 1
- Regulation: 21 CFR 862.1030
- 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K991834: Cholestech LDX Alanine Aminotransferase (Alt), Model 11-772 (1999), 0 descendants of its own

## Recalls of this device
- Jul 14, 2004 · Not classified · Z-1303-04: Coating defect may result is falsely decreased patient and/or control results.

Source page: https://510kreport.com/device/K864082
Methodology: https://510kreport.com/methodology