# K971637: Compound Sulphonamides Antimicrobial Susceptibility Test Disc

- Pathway: 510(k) (Traditional)
- Applicant: Oxoid, Ltd.
- Decided: Dec 23, 1997 after 235 days
- Product code: JTN (Susceptibility Test Discs, Antimicrobial)
- Device class: 2
- Regulation: 21 CFR 866.1620
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) BBL Sensi-Disc Sulphonamides 300ug/mL Sensi-Disc - Antimicrobial Susceptibility Test Disc: named in the summary without a submission number

## Indications for use
Antimicrobial Susceptibility Test Discs are indicated for the seml-quanntatwe susceptibility testing by agar diffusion test procedure of rapidly growing micro-organisms. These include : Enierobacteriacae, Pseud. aeruginosa, Acinetobacter spp., and Staphylococcus spp. The technical product insert detaiis the Quality Control organisms to be use with this disc.

Source page: https://510kreport.com/device/K971637
Methodology: https://510kreport.com/methodology