VARELISA RNP ANTIBODIES
FDA 510(k) clearance K993589 · decided 1999-11-26
Clearance details
- K-number
- K993589
- Device name
- VARELISA RNP ANTIBODIES
- Applicant
- Pharmacia & Upjohn Co.
- Decision
- Substantially Equivalent
- Date received
- 1999-10-22
- Decision date
- 1999-11-26
- Days to decision
- 35 days
- Clearance type
- Traditional
- Product code
- LKO
- Device class
- 2
- Regulation number
- 866.5100
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Westervillle, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.