# K934550: Immunocard Mycoplasma

- Pathway: 510(k) (Traditional)
- Applicant: Meridian Diagnostics, Inc.
- Decided: Sep 20, 1994 after 363 days
- Product code: LJZ (Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.)
- Device class: 1
- Regulation: 21 CFR 866.3375
- 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.
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
- Feb 8, 2021 · Class II · Z-1299-2021: Use of the kits after incorrect storage could lead to a potential false-negative or invalid result. In the event of a false-negative, the incorrect assumption would be made as to the cause of patient 

Source page: https://510kreport.com/device/K934550
Methodology: https://510kreport.com/methodology