# K982871: Drug Calibrator II

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Oct 13, 1998 after 60 days
- Product code: DKB (Calibrators, Drug Mixture)
- 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 K962817 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962817: Drug Calibrator II, Dade Intl., Inc. (1996) Summary page 1.

## Indications for use
Drug Calibrator Il is an in vitro diagnostic product intended for use in an in vitro test system to establish points of reference that are used in the determination of values in the measurement of human substances.

Source page: https://510kreport.com/device/K982871
Methodology: https://510kreport.com/methodology