# K023312: Control Plasma P

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Nov 1, 2002 after 29 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
Longest line of descent: 1 generation back to K924405 (1992). 1 ancestor in all.
1 later device descends from it; 1 cites 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)
- K924405: Control Plasma P, Behring Diagnostics, Inc. (1992) Summary page 2.

## Most influential descendants
- K042209: Control Plasma N and Control Plasma P (2004), 0 descendants of its own

## Indications for use
Control Plasma P is assayed for use as an accuracy control of the following parameters in the pathological range: 7. Prothrombin time (PT) 2. Activated partial thromboplastin time (aPTT) 3, Fibrinogen (Clauss method) 4. Ccmgukdionicrt-iars i i , V, iiii, Viii, vkVF, iii, XI Xi, ana X I I 5. Inhibitors: Antithrombin Ill, protein C, protein S, a:-antiplasrnin 6. Plasminogen

Source page: https://510kreport.com/device/K023312
Methodology: https://510kreport.com/methodology