# K842579: B.E.C. Growth Chek Microbial Suspensions

- Pathway: 510(k) (Traditional)
- Applicant: Biological & Environmental Control Laboratories
- Decided: Jul 27, 1984 after 24 days
- Product code: JTR (Kit, Quality Control For Culture Media)
- Device class: 1
- Regulation: 21 CFR 866.2480
- 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
- Jan 13, 2009 · Not classified · Z-1043-2009: Candida albicans microbial suspension, certified to deliver less than 100 organisms per dose, was found to have a population count which exceeded 100 organisms per dose, following distribution.

Source page: https://510kreport.com/device/K842579
Methodology: https://510kreport.com/methodology