FDA 510(k)

MICROLET®NEXT 2 Lancing Device

K-번호: K250813 · 2025-05-14

결정일2025-05-14

제품 코드QRL

자문 위원회SU

결정Substantially Equivalent

기기 요약

MICROLET®NEXT 2 Lancing Device is the device name listed in this FDA 510(k) record. The listed applicant is Ascensia Diabetes Care U.S., Inc.. It received FDA 510(k) clearance on 2025-05-14 under 510(k) number K250813. The device is classified under product code QRL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the MICROLET®NEXT 2 Lancing Device?

MICROLET®NEXT 2 Lancing Device is a medical device that received FDA 510(k) clearance on 2025-05-14. The listed applicant is Ascensia Diabetes Care U.S., Inc.. The 510(k) number is K250813.

When did MICROLET®NEXT 2 Lancing Device receive FDA 510(k) clearance?

MICROLET®NEXT 2 Lancing Device received FDA 510(k) clearance on 2025-05-14, under 510(k) number K250813.

Who is the listed applicant for MICROLET®NEXT 2 Lancing Device?

The FDA 510(k) record lists Ascensia Diabetes Care U.S., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICROLET®NEXT 2 Lancing Device?

The FDA product code for MICROLET®NEXT 2 Lancing Device is QRL.

Ascensia Diabetes Care U.S., Inc.를 신청인으로 등재한 기타 기록

K241787CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System K241810MICROLET®NEXT Lancet K223293CONTOUR® NEXT GEN Blood Glucose Monitoring System K220633MICROLET NEXT lancing device, MICROLET Lancet K162336Contour Next EZ Blood Glucose Monitoring System K160430Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System

7개 장치 모두 보기 →

공식 출처

FDA 데이터베이스에서 보기 →

FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.