# K934314: Tintelizer (R) Tpa

- Pathway: 510(k) (Traditional)
- Applicant: Biopool AB
- Decided: Feb 23, 1994 after 175 days
- Product code: GGP (Test, Qualitative And Quantitative Factor Deficiency)
- Device class: 2
- Regulation: 21 CFR 864.7290
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices 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.

## Most influential descendants
- K013492: Imubind Tpa Elisa, Model 860 (2002), 0 descendants of its own
- K971519: Asserachrom Tpa Test Kit (1997), 0 descendants of its own

Source page: https://510kreport.com/device/K934314
Methodology: https://510kreport.com/methodology