# K863821: Mueller Hinton Agar W/4%Nacl and Oxacillin

- Pathway: 510(k) (Traditional)
- Applicant: Gibco Laboratories Life Technologies, Inc.
- Decided: Oct 9, 1986 after 9 days
- Product code: JTZ (Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth)
- Device class: 2
- Regulation: 21 CFR 866.1700
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
17 later devices descend from it; 5 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K042812: Bblchromagar Mrsa (2004), 12 descendants of its own
- K071026: BD Geneohm Staphsr Assay (2007), 9 descendants of its own
- K070361: Mrsaselect (2007), 4 descendants of its own
- K082140: Xpert Mrsa/SA Blood Culture Assay (2008), 3 descendants of its own
- K081212: Mrsaselect - Extended Incubation (2008), 3 descendants of its own

## Recalls of this device
- Apr 20, 2011 · Not classified · Z-2608-2011: Oxacillin Screen Agar may not have been produced according to specification and could result in false antibiotic susceptibility test results in patient specimens.

Source page: https://510kreport.com/device/K863821
Methodology: https://510kreport.com/methodology