VARELISA M2 ANTIBODIES
FDA 510(k) clearance K945607 · decided 1995-01-24
Clearance details
- K-number
- K945607
- Device name
- VARELISA M2 ANTIBODIES
- Applicant
- Elias U.S.A., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-11-15
- Decision date
- 1995-01-24
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- DBM
- Device class
- 2
- Regulation number
- 866.5090
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Osceola, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.