# K892928: Haemophilus Test Medium (Agar)

- Pathway: 510(k) (Traditional)
- Applicant: Remel Co.
- Decided: Jun 13, 1989 after 53 days
- Product code: JSO (Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar)
- Device class: 2
- Regulation: 21 CFR 866.1700
- Recalls of this device: 5 (0 Class I)
- 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 has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- May 31, 2023 · Class II · Z-2038-2023: The test medium may not perform as intended.
- Mar 10, 2021 · Class II · Z-1424-2021: When tested with H. influenza ATCC 49247 and ATCC 49766 both organisms may exhibit lighter than normal growth making zones difficult to measure.
- Mar 10, 2021 · Class II · Z-1425-2021: When tested with H. influenza ATCC 49247 and ATCC 49766 both organisms may exhibit lighter than normal growth making zones difficult to measure.
- Apr 21, 2011 · Not classified · Z-2929-2011: Organism strains may fail to consistently produce confluent growth
- Apr 21, 2011 · Not classified · Z-2928-2011: Organism strains may fail to consistently produce confluent growth

Source page: https://510kreport.com/device/K892928
Methodology: https://510kreport.com/methodology