BCR-30-min BI and RBIP-ST30 Readout Accessory— 510(k) K151482
Substantially EquivalentBcr Diagnostics, Inc.
FDA 510(k) clearance K151482 for BCR-30-min BI and RBIP-ST30 Readout Accessory, Substantially Equivalent on 2016-02-26. Applicant: Bcr Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Bcr Diagnostics, Inc.
- Product code
- Code FRC
- Device class
- Class 2
- Regulation
- 21 CFR 880.2800
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Phoenix, AZ, US
Recent devices under product code FRC
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