ALPHA-2 MACROGLOBULIN TEST RID KIT
FDA 510(k) clearance K914389 · decided 1991-12-20
Clearance details
- K-number
- K914389
- Device name
- ALPHA-2 MACROGLOBULIN TEST RID KIT
- Applicant
- The Binding Site, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1991-10-01
- Decision date
- 1991-12-20
- Days to decision
- 80 days
- Clearance type
- Traditional
- Product code
- DEB
- Device class
- 2
- Regulation number
- 866.5620
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Los Angeles, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.