# K964062: N Protein Strandard SL

- Pathway: 510(k) (Traditional)
- Applicant: Behring Diagnostics, Inc.
- Decided: Nov 21, 1996 after 42 days
- Product code: JIX (Calibrator, Multi-Analyte Mixture)
- Device class: 2
- Regulation: 21 CFR 862.1150
- 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. The FDA summary names its predicate without a number.
- (no number) N Protein Standard SY: named in the summary without a submission number

## Most influential descendants
- K153560: Optilite Low Level Albumin Kit (2016), 0 descendants of its own
- K991181: Modification of N Protein Standard SL (1999), 0 descendants of its own

## Indications for use
N Protein Standard SL is intended to be used for the establishment of reference curves.

Source page: https://510kreport.com/device/K964062
Methodology: https://510kreport.com/methodology