QM300 ALPHA1-ACID GLYCOPROTEIN ANTIBODY PACK
FDA 510(k) clearance K894538 · decided 1989-08-04
Clearance details
- K-number
- K894538
- Device name
- QM300 ALPHA1-ACID GLYCOPROTEIN ANTIBODY PACK
- Applicant
- Kallestad Diag, A Div. of Erbamont, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-07-20
- Decision date
- 1989-08-04
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- DBN
- Device class
- 1
- Regulation number
- 866.5530
- 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.