Safety Blood Collection Needles with/without Needle Holder
FDA 510(k) clearance K220900 · decided 2022-08-10
Clearance details
- K-number
- K220900
- Device name
- Safety Blood Collection Needles with/without Needle Holder
- Applicant
- Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2022-03-28
- Decision date
- 2022-08-10
- Days to decision
- 135 days
- Clearance type
- Traditional
- Product code
- JKA
- Device class
- 2
- Regulation number
- 862.1675
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Anqing, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.