# K971287: Synchron Systems Drug Calibration 3 Plus

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Instruments, Inc.
- Decided: May 8, 1997 after 31 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 K955644 (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)
- K955644: Synchron Systems Carbamazepine Test System, Beckman Instruments, Inc. (1996) Summary page 1.

## Indications for use
The SYNCHRON® Systems DRUG CALIBRATOR 3 PLUS, when used in conjunction with SYNCHRON Gentamicin Reagent and Tobramycin Reagent, is intended for use on the SYNCHRON Systems and for the calibration of gentamicin and tobramycin.

Source page: https://510kreport.com/device/K971287
Methodology: https://510kreport.com/methodology