IMMUNO CONCEPTS ANCA TEST SYSTEM— 510(k) K974463
Substantially EquivalentImmuno Concepts, Inc.
FDA 510(k) clearance K974463 for IMMUNO CONCEPTS ANCA TEST SYSTEM, Substantially Equivalent on 1998-02-09. 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
Recent devices under product code MOB
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- K173792 — EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay
More clearances from Immuno Concepts, Inc.
view all- K013432 — IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040G
- K013283 — RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16
- K013285 — RELISA MPO-ANCA TEST SYSTEM FOR ANTIBODIES TO MYELOPEROXIDASE, MODEL # 7096-15
- K992041 — RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11
- K983924 — HEP-2000 COLORZYME ANA-RO TEST SYSTEM, MODEL 4200-RO
Data sourced from openFDA. This site is unofficial and independent of the FDA.