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).
| Device ID | K220475 |
| 510k Number | K220475 |
| 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) |
| Classification | Multiple 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 |
| Contact | Yuan Ying |
| Correspondent | Stuart Situ Landlink Healthcare Technology (Shanghai) Co., Ltd Room 1308, Baohua International Plaza, West Guangzhong Road 555, Jingan District Shanghai, CN 200072 |
| Product Code | QRL |
| CFR Regulation Number | 878.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-18 |
| Decision Date | 2022-07-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00015482880187 | K220475 | 000 |
| 10015482880160 | K220475 | 000 |
| 00860011521242 | K220475 | 000 |
| 00860011521235 | K220475 | 000 |