# Skyla Corporation H.S.P.B

- Location (FDA's records): Hsinchu City, TW
- FDA decisions: 1 (2018–2018): 1 510(k) clearance
- Product codes: LCP (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Alere Technologies AS: 1 (https://510kreport.com/company/alere-technologies)

## Recent decisions
- K173127: skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit) (Sep 25, 2018)

Source page: https://510kreport.com/company/skyla-hspb