# K823213: Diagnostics Alkaline Phosphatase Optimi

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Nov 22, 1982 after 25 days
- Product code: CJE (Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes)
- Device class: 2
- Regulation: 21 CFR 862.1050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 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
- K981806: ALKP (1998), 3 descendants of its own
- K023807: Modification to Alkp (2002), 2 descendants of its own
- K240468: Alkaline Phosphatase (2024), 0 descendants of its own
- K223317: Alkaline Phosphatase2 (2023), 0 descendants of its own

Source page: https://510kreport.com/device/K823213
Methodology: https://510kreport.com/methodology