# K000494: Synchron Systems Acetaminophen (Actm) Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Apr 14, 2000 after 59 days
- Product code: LDP (Colorimetry, Acetaminophen)
- Device class: 2
- Regulation: 21 CFR 862.3030
- 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 has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Jul 10, 2008 · Not classified · Z-2405-2008: This recall was initiated after Beckman Coulter verified through testing that Acetaminophen reagents (lots #M702524 & M703276) manufactured with contaminated heparin has shown a negative bias in perfo

Source page: https://510kreport.com/device/K000494
Methodology: https://510kreport.com/methodology