VISUWELL REAGIN II— 510(k) K952802
Substantially EquivalentBiomira Diagnostics, Inc.
FDA 510(k) clearance K952802 for VISUWELL REAGIN II, Substantially Equivalent on 1996-05-23. Applicant: Biomira Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Biomira Diagnostics, Inc.
- Product code
- Code GMQ
- Device class
- Class 2
- Regulation
- 21 CFR 866.3820
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rexdale, Ontario, CA
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