Safety Blood Collection Sets for Single Use— 510(k) K202188
Substantially EquivalentAnhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
FDA 510(k) clearance K202188 for Safety Blood Collection Sets for Single Use, Substantially Equivalent on 2021-02-19. Applicant: Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
- Product code
- Product code JKA
- Device class
- Class 2
- Regulation
- 21 CFR 862.1675
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Taihu, Anqing City, CN
Recent devices under product code JKA
view all- K262242 — Profoject Safe Push Button Blood Collection Sets
- K260857 — Sol-Guard Safety Pull Button Collection Set; Sol-Guard XtraThin Safety Pull-Button Blood Collection Set
- K252344 — BD Vacutainer® Serum Blood Collection Tubes; BD Vacutainer® Rapid Serum Tubes (RST)
- K262215 — Profoject Safety Sliding Blood Collection Set
- K252899 — Female Culture Device; Male Culture Device; Transfer Device; Access Device
More clearances from Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
view allAdverse events under product code JKA
product code JKA- Injury
- 455
- Malfunction
- 26,686
- Other
- 4
- Total
- 27,145
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.