VARELISA SM ANTIBODIES, MODEL 18296
FDA 510(k) clearance K042629 · decided 2004-12-08
Clearance details
- K-number
- K042629
- Device name
- VARELISA SM ANTIBODIES, MODEL 18296
- Applicant
- Sweden Diagnostics (Germany) GmbH
- Decision
- Substantially Equivalent
- Date received
- 2004-09-27
- Decision date
- 2004-12-08
- Days to decision
- 72 days
- Clearance type
- Traditional
- Product code
- LKP
- Device class
- 2
- Regulation number
- 866.5100
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Freiburg, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.