QM300 APOLIPOPROTEIN B ANTIBODY PACK— 510(k) K883714
Substantially EquivalentKallestad Diag, A Div. of Erbamont, Inc.
FDA 510(k) clearance K883714 for QM300 APOLIPOPROTEIN B ANTIBODY PACK, Substantially Equivalent on 1988-10-19. Applicant: Kallestad Diag, A Div. of Erbamont, Inc.. Device class: 1.
Clearance details
- Applicant
- Kallestad Diag, A Div. of Erbamont, Inc.
- Product code
- Code MSJ
- Device class
- Class 1
- Regulation
- 21 CFR 862.1475
- Advisory panel
- Clinical Chemistry
- 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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