# K771603: Immochemistry System

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Instruments, Inc.
- Decided: Sep 15, 1977 after 24 days
- Product code: CZP (Iga, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5510
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
19 later devices descend from it; 7 cite it directly.
0 of 20 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
- K963868: Immage Immunochemistry System Immunoglobulin G (Igg), a (Iga) and M (Igm) (1997), 7 descendants of its own
- K973932: Beckman Calibrator 2 (CAL2) (1997), 4 descendants of its own
- K964766: Immage Immunochemistry System Alpha-1-Antitrypsin (Aat) (1997), 4 descendants of its own
- K052819: Vitros Chemistry Products Aat Reagent, Calibrator Kit 99 and Aat Performance Verifiers I, II and Iii (2005), 3 descendants of its own
- K993549: Beckman Coulter Immage Immunochemistry System Low Concentration Immunoglobulin a (Igalc) Reagent, Beckman Coulter Cerebr (2000), 3 descendants of its own

Source page: https://510kreport.com/device/K771603
Methodology: https://510kreport.com/methodology