RELISA MPO-ANCA TEST SYSTEM FOR ANTIBODIES TO MYELOPEROXIDASE, MODEL # 7096-15— 510(k) K013285
Substantially EquivalentImmuno Concepts, Inc.
FDA 510(k) clearance K013285 for RELISA MPO-ANCA TEST SYSTEM FOR ANTIBODIES TO MYELOPEROXIDASE, MODEL # 7096-15, Substantially Equivalent on 2001-11-14. Applicant: Immuno Concepts, Inc.. Device class: 2.
Clearance details
- Applicant
- Immuno Concepts, 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
- Dallas, TX, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.