Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Blood
FDA 510(k) clearance K230080 · decided 2023-07-07
Clearance details
- K-number
- K230080
- Device name
- Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Blood
- Applicant
- Yangzhou Medline Industry, Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2023-01-11
- Decision date
- 2023-07-07
- Days to decision
- 177 days
- Clearance type
- Traditional
- Product code
- JKA
- Device class
- 2
- Regulation number
- 862.1675
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Yangzhou, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.