BVBLUE— 510(k) K993732
Substantially EquivalentGryphus Diagnostics, LLC
FDA 510(k) clearance K993732 for BVBLUE, Substantially Equivalent on 2000-05-15. Applicant: Gryphus Diagnostics, LLC. Device class: 1.
Clearance details
- Applicant
- Gryphus Diagnostics, LLC
- Product code
- Code MXB
- Device class
- Class 1
- Regulation
- 21 CFR 866.2660
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rockville, MD, US
Recent devices under product code MXB
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