RADIAL IMMUNODIFFUSION PLATES ALPHA-2 MACROGLOBULI— 510(k) K851282
Substantially EquivalentCooper Biomedical, Inc.
FDA 510(k) clearance K851282 for RADIAL IMMUNODIFFUSION PLATES ALPHA-2 MACROGLOBULI, Substantially Equivalent on 1985-05-24. Applicant: Cooper Biomedical, Inc.. Device class: 2.
Clearance details
- Applicant
- Cooper Biomedical, Inc.
- Product code
- Code DEB
- Device class
- Class 2
- Regulation
- 21 CFR 866.5620
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Malvern, PA, US
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