RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L— 510(k) K011068
Substantially EquivalentRhigene, Inc.
FDA 510(k) clearance K011068 for RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L, Substantially Equivalent on 2002-04-11. Applicant: Rhigene, Inc.. Device class: 2.
Clearance details
- Applicant
- Rhigene, Inc.
- Product code
- Code KTL
- Device class
- Class 2
- Regulation
- 21 CFR 866.5100
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Des Plaines, IL, US
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