# K972409: AG Chemistry Analyzer System

- Pathway: 510(k) (Traditional)
- Applicant: Landmark Scientific, Inc.
- Decided: Aug 28, 1997 after 63 days
- Product code: JJG (Analyzer, Chemistry, Centrifugal, For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2140
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K781900 (1978). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K781900: Analyzer, Automed Centrifugal, Autogenic Systems (1978) Summary page 1.
- K853453: Bio Automed Sys Chemistry Analyzer Auto-Loader, Bio Automed Systems, Inc. (1985) Summary page 1.

## Indications for use
The AG" Chemistry Analyzer is indicated for in vitro diagnostic use for the quanititative determination of body fluid constituents using automated spectrophotometric methods.

Source page: https://510kreport.com/device/K972409
Methodology: https://510kreport.com/methodology