COLORZYME NDNA TEST SYSTEM— 510(k) K843225
Substantially EquivalentImmuno Concepts, Inc.
FDA 510(k) clearance K843225 for COLORZYME NDNA TEST SYSTEM, Substantially Equivalent on 1984-11-01. Applicant: Immuno Concepts, Inc.. Device class: 2.
Clearance details
- Applicant
- Immuno Concepts, Inc.
- Product code
- Code DHN
- Device class
- Class 2
- Regulation
- 21 CFR 866.5100
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sacramento, CA, US
Recent devices under product code DHN
view allMore 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.