TINA-QUANT ALPHA PARTICLE-1-ANTITRYPSIN ASSAY— 510(k) K972640
Substantially EquivalentBoehringer Mannheim Corp.
FDA 510(k) clearance K972640 for TINA-QUANT ALPHA PARTICLE-1-ANTITRYPSIN ASSAY, Substantially Equivalent on 1998-01-09. Applicant: Boehringer Mannheim Corp.. Device class: 2.
Clearance details
- Applicant
- Boehringer Mannheim Corp.
- 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
- Concord, CA, US
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More clearances from Boehringer Mannheim Corp.
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