Kurin Blood Culture Collection Set with Kurin Lock Technology
FDA 510(k) clearance K220677 · decided 2023-04-28
Clearance details
- K-number
- K220677
- Device name
- Kurin Blood Culture Collection Set with Kurin Lock Technology
- Applicant
- Kurin, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-03-08
- Decision date
- 2023-04-28
- Days to decision
- 416 days
- Clearance type
- Traditional
- Product code
- JKA
- Device class
- 2
- Regulation number
- 862.1675
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.