QM300 ALPHA1-ANTITRYPSIN ANTIBODY PACK— 510(k) K875281
Substantially EquivalentKallestad Diag, A Div. of Erbamont, Inc.
FDA 510(k) clearance K875281 for QM300 ALPHA1-ANTITRYPSIN ANTIBODY PACK, Substantially Equivalent on 1988-02-10. Applicant: Kallestad Diag, A Div. of Erbamont, Inc.. Device class: 2.
Clearance details
- Applicant
- Kallestad Diag, A Div. of Erbamont, Inc.
- Product code
- Code DEM
- Device class
- Class 2
- Regulation
- 21 CFR 866.5130
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chaska, MN, US
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More clearances from Kallestad Diag, A Div. of Erbamont, Inc.
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