Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Blood— 510(k) K230080
Substantially EquivalentYangzhou Medline Industry, Co., Ltd.
FDA 510(k) clearance K230080 for Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Blood, Substantially Equivalent on 2023-07-07. Applicant: Yangzhou Medline Industry, Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Yangzhou Medline Industry, 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
- Yangzhou, CN
Recent devices under product code JKA
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- K262215 — Profoject Safety Sliding Blood Collection Set
- K252899 — Female Culture Device; Male Culture Device; Transfer Device; Access Device
More clearances from Yangzhou Medline Industry, 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.