# K960257: N Antiserum to C1 Inhibitor

- Pathway: 510(k) (Traditional)
- Applicant: Behring Diagnostics, Inc.
- Decided: Aug 1, 1996 after 196 days
- Product code: DBA (Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5250
- 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) Bind a Rid™ C1: 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
In vitro diagnostic reagent for the quantitative determination of C1 Inhibitor (C1-inactivator, C1-esterase inhibitor) in human plasma and serum with the Behring Nephelometers. Measurement of C1 inhibitor aids in the diagnosis of hereditary angioneurotic edema (increased blood vessel permeability causing swelling of tissues) and a rare form of angioedema associated with lymphoma (lymph node cancer).

Source page: https://510kreport.com/device/K960257
Methodology: https://510kreport.com/methodology