# K020845: Emit 2000 Vancomycin Calibrators

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: May 8, 2002 after 54 days
- Product code: DLJ (Calibrators, Drug Specific)
- Device class: 2
- Regulation: 21 CFR 862.3200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K881040 (1988). 1 ancestor in all.
1 later device descends from it; 1 cites 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)
- K881040: Emit Vancomycin Assay, Syva Co. (1988) Summary page 1.

## Most influential descendants
- K043386: Vitros Chemistry Products Vanc Reagent, Calibrator Kit 11 and TDM Performance Verifiers I, II and Iii (2005), 0 descendants of its own

## Indications for use
The Emit® 2000 Vancomycin Calibrators are intended for use with the Emit® 2000 Vancomycin Assay as a reference for use in determining vancomycin levels in human serum or plasma.

Source page: https://510kreport.com/device/K020845
Methodology: https://510kreport.com/methodology