Kurin Blood Culture Collection Set with Kurin Lock Technology— 510(k) K220677
Substantially EquivalentKurin, Inc.
FDA 510(k) clearance K220677 for Kurin Blood Culture Collection Set with Kurin Lock Technology, Substantially Equivalent on 2023-04-28. Applicant: Kurin, Inc.. Device class: 2.
Clearance details
- Applicant
- Kurin, Inc.
- Product code
- 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
- San Diego, CA, US
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More clearances from Kurin, Inc.
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.