Lancet (I, II, III, V, VI); Lancing Device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T)

Multiple Use Blood Lancet For Single Patient Use Only

Tianjin Huahong Technology Co., Ltd.

The following data is part of a premarket notification filed by Tianjin Huahong Technology Co., Ltd. with the FDA for Lancet (i, Ii, Iii, V, Vi); Lancing Device (hh-x-t, Hh-xiii-t, Hh-xv-t, Hh-xvi-t, Hh-xvii-t, Hh-xviii-t, Hh-xix, Hh-xxi-t, Hh-xxii-t, Hh-xxiii-t, Hh-xxiv-t).

Pre-market Notification Details

Device IDK220475
510k NumberK220475
Device Name:Lancet (I, II, III, V, VI); Lancing Device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T)
ClassificationMultiple Use Blood Lancet For Single Patient Use Only
Applicant Tianjin Huahong Technology Co., Ltd. A01, Plant B, No. 278, Hangkong Road Tianjin Pilot Free Trade Zone(Air Port Industrial Park) Tianjian,  CN 300308
ContactYuan Ying
CorrespondentStuart Situ
Landlink Healthcare Technology (Shanghai) Co., Ltd Room 1308, Baohua International Plaza, West Guangzhong Road 555, Jingan District Shanghai,  CN 200072
Product CodeQRL  
CFR Regulation Number878.4850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-02-18
Decision Date2022-07-06

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