# K965152: A.C.T. II

- Pathway: 510(k) (Traditional)
- Applicant: Remel Co.
- Decided: Jan 22, 1997 after 30 days
- Product code: JSM (Culture Media, Non-Propagating Transport)
- Device class: 1
- Regulation: 21 CFR 866.2390
- 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Jan 18, 2010 · Not classified · Z-1139-2010: Pouch may be inadequately heat sealed compromising sterility

Source page: https://510kreport.com/device/K965152
Methodology: https://510kreport.com/methodology