QM300 ALPHA2 MACROGLOBULIN ANTIBODY PACK
FDA 510(k) clearance K896483 · decided 1989-12-01
Clearance details
- K-number
- K896483
- Device name
- QM300 ALPHA2 MACROGLOBULIN ANTIBODY PACK
- Applicant
- Kallestad Diag, A Div. of Erbamont, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-11-13
- Decision date
- 1989-12-01
- Days to decision
- 18 days
- Clearance type
- Traditional
- Product code
- DEB
- Device class
- 2
- Regulation number
- 866.5620
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Chaska, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.