# K962407: N/T Protein Control PY

- Pathway: 510(k) (Traditional)
- Applicant: Behring Diagnostics, Inc.
- Decided: Jul 29, 1996 after 38 days
- Product code: GIL (Plasma, Fibrinogen Control)
- Device class: 2
- Regulation: 21 CFR 864.7340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Control Plasma N: named in the summary without a submission number

## Most influential descendants
- K072965: Dimension Vista C1 in; Flex Reagent Cartridge, Cal, Con (2007), 0 descendants of its own

## Indications for use
N/T Protein Control PY is used for control of accuracy and precision in the quantitative immunochemical determination of alpha₁-Antitrypsin, fibrinogen, antithrombin III, prothrombin, plasminogen, fibronectin®, C4 Inhibitor with the Behring Nephelometer Systems and with the TurbiTimeSystem.

Source page: https://510kreport.com/device/K962407
Methodology: https://510kreport.com/methodology