# K002974: Emit Tox Acetaminophen Assay, Model 7A319UL; Emit Tox Ecetaminophen Calibrators, Model 7A409UL

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Oct 11, 2000 after 55 days
- Product code: LDP (Colorimetry, Acetaminophen)
- Device class: 2
- Regulation: 21 CFR 862.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 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
- K261364: Atellica CH Acetaminophen 2 (ACTM) (2026), 0 descendants of its own
- K141928: Cobas C Acetaminophen Gen.2 Assay, ACET2 Calibrator (2014), 0 descendants of its own

Source page: https://510kreport.com/device/K002974
Methodology: https://510kreport.com/methodology