MININEPH A-1 ANTITRYPSIN ANTISERUM, HIGH AND LOW SERUM CONTROLS
FDA 510(k) clearance K011663 · decided 2001-07-30
Clearance details
- K-number
- K011663
- Device name
- MININEPH A-1 ANTITRYPSIN ANTISERUM, HIGH AND LOW SERUM CONTROLS
- Applicant
- The Binding Site, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2001-05-29
- Decision date
- 2001-07-30
- Days to decision
- 62 days
- Clearance type
- Traditional
- Product code
- DEM
- Device class
- 2
- Regulation number
- 866.5130
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Santa Monica, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.