OneTouch Delica Plus Lancing System— 510(k) K221546

Substantially Equivalent

Asahi Polyslider Co., Ltd.

FDA 510(k) clearance K221546 for OneTouch Delica Plus Lancing System, Substantially Equivalent on 2022-08-23. Applicant: Asahi Polyslider Co., Ltd..

Clearance details

Applicant
Asahi Polyslider Co., Ltd.
Product code
Code QRL
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Maniwa, JP
Download summary PDFView on FDA.gov ↗

Adverse events under product code QRL

product code QRL
Other
1
Total
1

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.