# K961370: LA Positive Control Plasma

- Pathway: 510(k) (Traditional)
- Applicant: Medical Diagnostic Technologies, Inc.
- Decided: May 24, 1996 after 45 days
- Product code: GGC (Control, Plasma, Abnormal)
- 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.
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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K020109: Sigma Diagnostics Accuclot LA Control (2002), 0 descendants of its own
- K993332: Gradiplasma LA High, Gradiplasma LA Low Models Lahp-1, Lahp-05, Lalp-1, Lalp-05 (2000), 0 descendants of its own

Source page: https://510kreport.com/device/K961370
Methodology: https://510kreport.com/methodology