MESACUP TEST MPO, MODEL 11053— 510(k) K040586
Substantially EquivalentRhigene, Inc.
FDA 510(k) clearance K040586 for MESACUP TEST MPO, MODEL 11053, Substantially Equivalent on 2004-03-22. Applicant: Rhigene, Inc.. Device class: 2.
Clearance details
- Applicant
- Rhigene, Inc.
- Product code
- Code MOB
- Device class
- Class 2
- Regulation
- 21 CFR 866.5660
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Westminster, CO, US
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