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510(k) K972145

HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM by Immuno Concepts, Inc. — Product Code DHN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 1998
Date Received
June 6, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

Other clearances by Immuno Concepts, Inc.

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  • K013285 — RELISA MPO-ANCA TEST SYSTEM FOR ANTIBODIES TO MYELOPEROXIDASE, MODEL # 7096-15 (November 14, 2001)
  • K992041 — RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11 (July 23, 1999)
  • K983924 — HEP-2000 COLORZYME ANA-RO TEST SYSTEM, MODEL 4200-RO (December 18, 1998)
  • K974463 — IMMUNO CONCEPTS ANCA TEST SYSTEM (February 9, 1998)
  • K974478 — IMMUNO CONCEPTS ANCA TEST SYSTEMS (February 9, 1998)
  • K963275 — RELISA ENA SINGLE WELL SCREEN ANTIBODY TEST SYSTEM (September 13, 1996)
  • K955602 — RELSIA SCL-70 ANTIBODY TEST SYSTEM (April 19, 1996)
  • K955605 — RELISA JO-1 ANTIBODY TEST SYSTEM (April 19, 1996)

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