# K971638: Clarithromycin Antimicrobial Susceptibility Test Disc

- Pathway: 510(k) (Traditional)
- Applicant: Oxoid, Ltd.
- Decided: Aug 20, 1997 after 110 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Antimicrobial Susceptibility Test Discs are indicated for the semi-quantitative susceptibility testing by agar diffusion test procedure of rapidly growing micro-organisms. These include : Staphylococcus spp., Meraxella catarrhalis, and some Streptococci, and by modified procedures, Haemophilus influenzae, Neisseria gonorrhoeae and Streptococcus pneumoniae. The technical product insert details the Quality Control organisms to be use with this disc.

Source page: https://510kreport.com/device/K971638
Methodology: https://510kreport.com/methodology