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FDA 510(k)

Accu-Chek Safe-T-Pro Plus Lancing Device

K-Number: K232488 · 2023-11-13

ApplicantRoche Diabetes Care, Inc.
Decision Date2023-11-13
Product CodeFMK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Accu-Chek Safe-T-Pro Plus Lancing Device is a medical device manufactured by Roche Diabetes Care, Inc.. It received FDA 510(k) clearance on 2023-11-13 under approval number K232488. The device is classified under product code FMK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Accu-Chek Safe-T-Pro Plus Lancing Device?

Accu-Chek Safe-T-Pro Plus Lancing Device is a medical device that received FDA 510(k) clearance on 2023-11-13. It is manufactured by Roche Diabetes Care, Inc.. The 510(k) number is K232488.

When was Accu-Chek Safe-T-Pro Plus Lancing Device approved by the FDA?

Accu-Chek Safe-T-Pro Plus Lancing Device received FDA 510(k) clearance on 2023-11-13, under approval number K232488.

What company makes Accu-Chek Safe-T-Pro Plus Lancing Device?

Accu-Chek Safe-T-Pro Plus Lancing Device is manufactured by Roche Diabetes Care, Inc..

What is the FDA product code for Accu-Chek Safe-T-Pro Plus Lancing Device?

The FDA product code for Accu-Chek Safe-T-Pro Plus Lancing Device is FMK.

Other Devices by Roche Diabetes Care, Inc.

K160944ACCU-CHEK Guide Blood Glucose Monitoring System K220849Accu-Chek Safe-T-Pro Plus Lancing Device K203711IWL2020 Blood Glucose Monitoring System K220608Accu-Chek FastClix Blood Lancing System K220364Accu-Chek Safe-T-Pro Uno Lancing Device K214022Accu-Chek Softclix Blood Lancing System

View all 8 devices →

Related Devices (Code: FMK)

K153670Genteel Lancing DeviceGenteel, LLC K172712gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel ToddlerGri Medical & Electronic Technology Co., Ltd. K193009Promisemed Heel Blood LancetPromisemed Hangzhou Meditech Co., Ltd. K192666Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety LancetPromisemed Hangzhou Meditech Co., Ltd. K210745Heel Incision Safety LancetSteriLance Medical (Suzhou), Inc. K223243BD Microtainer® Contact-Activated Lancets; BD Microtainer® Quikheel™ LancetsBecton, Dickinson and Company

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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