SAMPLOK LUER KIT
FDA 510(k) clearance K021941 · decided 2002-07-02
Clearance details
- K-number
- K021941
- Device name
- SAMPLOK LUER KIT
- Applicant
- Itl Corporation Pty, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2002-06-13
- Decision date
- 2002-07-02
- Days to decision
- 19 days
- Clearance type
- Special
- Product code
- JKA
- Device class
- 2
- Regulation number
- 862.1675
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Fyshwick, Canberra Act, AU
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.