BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119— 510(k) K003851
Substantially EquivalentBiocheck, Inc.
FDA 510(k) clearance K003851 for BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119, Substantially Equivalent on 2001-07-20. Applicant: Biocheck, Inc.. Device class: 2.
Clearance details
- Applicant
- Biocheck, Inc.
- 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
- Northridge, CA, US
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