# K963036: Mueller Hinton II Broth (Cation-Adjusted) with Lysed Horse Blood

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson Microbiology Systems
- Decided: Oct 7, 1996 after 63 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K913459 (1991). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913459: The E Test, Modification, Ab Biodisk (1991) Summary page 1.

## Most influential descendants
- K262163: BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton Broth (2026), 0 descendants of its own

## Indications for use
Use of BBL® Mueller Hinton II Broth (Cation-Adjusted) with Lysed Horse Blood is indicated when Streptococcus pneumoniae has been isolated in pure culture in the clinical laboratory, and a determination is desired as to whether the organism is susceptible, intermediate, or resistant to selected antimicrobial agents. In cases such as these, broth dilution antimicrobial susceptibility testing may be performed on BBL® Mueller Hinton II Broth (Cation-Adjusted) with Lysed Horse Blood, using cefaclor, cefotaxime, ceftrixone, cefuroxime, chloramphenicol, erythromycin, imipenem, penicillin, tetracycline, trimethoprim/sulfamethoxazole, and vancomycin.

Source page: https://510kreport.com/device/K963036
Methodology: https://510kreport.com/methodology