# K013423: Microscan Dried Gram Negative Overnight Mic/Combo Panels

- Pathway: 510(k) (Traditional)
- Applicant: Dade Microscan, Inc.
- Decided: Dec 12, 2001 after 71 days
- Product code: JWY (Manual Antimicrobial Susceptibility Test Systems)
- Device class: 2
- Regulation: 21 CFR 866.1640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K061536: Microscan Dried Gram Negative Mic/Combo Panels (2006), 0 descendants of its own

## Indications for use
To detect Escherichia coli, Klebsiella oxytoca, and K. pneumoniae strains suspectcd of harboring suspectcd extended spectrum beta-lactammase enzymcs.

Source page: https://510kreport.com/device/K013423
Methodology: https://510kreport.com/methodology