SPQ TEST SYSTEM FOR C-REACTIVE PROTEIN— 510(k) K851842
Substantially EquivalentAtlantic Antibodies
FDA 510(k) clearance K851842 for SPQ TEST SYSTEM FOR C-REACTIVE PROTEIN, Substantially Equivalent on 1985-06-05. Applicant: Atlantic Antibodies. Device class: 2.
Clearance details
- Applicant
- Atlantic Antibodies
- Product code
- Code DCK
- Device class
- Class 2
- Regulation
- 21 CFR 866.5270
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Scarborough, ME, US
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