# K943621: Rapid Yeast Plus System

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Diagnostic Systems, Inc.
- Decided: Jan 27, 1995 after 184 days
- Product code: JXB (Kit, Identification, Yeast)
- Device class: 1
- Regulation: 21 CFR 866.2660
- Recalls of this device: 2 (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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Apr 4, 2013 · Class II · Z-0530-2014: The two reagents supplied in the RapID Yeast Plus System kit (Reagent A and Reagent B) are mislabeled. The labels were reversed.
- Oct 28, 2009 · Not classified · Z-0870-2010: There is an error in Version 1.0.77 of the electronic code compendium (ERIC) software. The error is limited to the database corresponding to the R8311007 RapID Yeast Plus System. The database erroneou

Source page: https://510kreport.com/device/K943621
Methodology: https://510kreport.com/methodology