# K963641: Streptococcus Mic Panel

- Pathway: 510(k) (Traditional)
- Applicant: Dade Microscan, Inc.
- Decided: Dec 18, 1996 after 97 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.
36 later devices descend from it; 22 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K020556: Microscan Microstrep Plus Panel with Levofloxacin (2002), 4 descendants of its own
- K021169: Microstrep Plus Panel, Azithromycin (2002), 1 descendant of its own
- K021110: Microscan Microstrep Plus Panel New Antimicrobial- Ceftriaxone (2002), 1 descendant of its own
- K021111: Microscan Microstrep Plus Panel New Antimicrobial - Cefotaxime (2002), 1 descendant of its own
- K021188: Microscan Microstrep Plus Panel New Antimicrobial-Cefepime (2002), 1 descendant of its own

Source page: https://510kreport.com/device/K963641
Methodology: https://510kreport.com/methodology