# K002804: N Protein Standard SL

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Oct 5, 2000 after 27 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.
29 later devices descend from it; 1 cites it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K012470: Modification to N Protein Standard SL (2001), 28 descendants of its own
- K061338: Dimension Vista Iga Flex Reagent Cartridge Assay (2006), 7 descendants of its own
- K063663: Dimension Vista STFR Flex Reagent Cartridge and Protein 1 Calibrator and Control L, M and H (2007), 6 descendants of its own
- K061990: Dimension Vista Microalbumin Flex Reagent Cartridge; Protein 3 Calibrator; Protein 3 Control (2006), 6 descendants of its own
- K062055: Dimension Vista Protein 1 Calibrator, Control Low, Control Medium, Control High (2006), 6 descendants of its own

Source page: https://510kreport.com/device/K002804
Methodology: https://510kreport.com/methodology