# K963191: Cedia Antibiotic TDM Multi-Cals

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Sep 10, 1996 after 26 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 K912143 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912143: Cedia (R) Tobramycin Assay, Microgenics Corp. (1991) Summary page 1.
- K913470: Cedia (R) Gentamicin Assay, Microgenics Corp. (1991) Summary page 1.

## Indications for use
The CEDIA Antibiotic TDM Multi-Cals are used to calibrate the CEDIA assays for tobramycin and gentamicin in human serum and plasma.

Source page: https://510kreport.com/device/K963191
Methodology: https://510kreport.com/methodology