# K964065: N/T Protein Control SL

- Pathway: 510(k) (Traditional)
- Applicant: Behring Diagnostics, Inc.
- Decided: Nov 6, 1996 after 27 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- 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/T Protein Control SY: named in the summary without a submission number

## Most influential descendants
- K153560: Optilite Low Level Albumin Kit (2016), 0 descendants of its own
- K991182: Modification of N/T Protein Control SL (1999), 0 descendants of its own

## Indications for use
N/T Protein Control SL is intended to be used as accuracy and precision controls in the determination of human serum proteins.

Source page: https://510kreport.com/device/K964065
Methodology: https://510kreport.com/methodology