# K905203: Coagulation Reference Plasma, Normal

- Pathway: 510(k) (Traditional)
- Applicant: Medical Diagnostic Technologies, Inc.
- Decided: Dec 28, 1990 after 38 days
- Product code: GIZ (Plasma, Control, Normal)
- Device class: 2
- Regulation: 21 CFR 864.5425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 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
- K041905: Hemosil Calibration Plasma (2004), 4 descendants of its own
- K090563: Hemosil Inr Validate, Hemosil Isi Calibrate, Isiweb (Software) (2009), 1 descendant of its own
- K173202: CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set (2018), 0 descendants of its own
- K093848: PT-Multi-Calibrator, Model OPAT07 (2010), 0 descendants of its own
- K092113: Sta - Free PS Calibrator (2009), 0 descendants of its own

Source page: https://510kreport.com/device/K905203
Methodology: https://510kreport.com/methodology