# K981734: Vtec-Rpla Seiken

- Pathway: 510(k) (Traditional)
- Applicant: Denka Seiken'S
- Decided: Sep 22, 1998 after 127 days
- Product code: GNA (Antisera, All Types, Escherichia Coli)
- Device class: 1
- Regulation: 21 CFR 866.3255
- Recalls of this device: none
- 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. The FDA summary names its predicate without a number.
- (no number) Premier EHEC: named in the summary without a submission number

## Indications for use
VTEC-RPLA "SEIKEN" is an in vitro diagnostic device for the detection and identification of verotoxin 1 and 2 in culture isolates of E. coli and is intended as an aid in the diagnosis of Enterohemorrhagic E. coli (EHEC) infections.

Source page: https://510kreport.com/device/K981734
Methodology: https://510kreport.com/methodology