# P980046: Home Access Hepatitis C Check and Hepatitis C Check Express

- Pathway: PMA
- Applicant: Pwn Health Chicago, LLC
- Decided: Apr 28, 1999 after 142 days
- Product code: QRO
- Device class: III
- 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. PMA decisions do not claim a predicate device.

## Recalls of this device
- Oct 6, 2006 · Not classified · Z-0150-2007: Wrong Expiration Date; The kits were labeled with Expiration/Use By dates; that exceed the expiration dates of the sterile safety lancet component of the kit.

Source page: https://510kreport.com/device/P980046
Methodology: https://510kreport.com/methodology