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510(k) K963275

RELISA ENA SINGLE WELL SCREEN ANTIBODY TEST SYSTEM by Immuno Concepts, Inc. — Product Code LLL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 1996
Date Received
August 20, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Immuno Concepts, Inc.

  • K013432 — IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040G (November 29, 2001)
  • K013285 — RELISA MPO-ANCA TEST SYSTEM FOR ANTIBODIES TO MYELOPEROXIDASE, MODEL # 7096-15 (November 14, 2001)
  • K013283 — RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16 (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)
  • K972145 — HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM (February 24, 1998)
  • K974463 — IMMUNO CONCEPTS ANCA TEST SYSTEM (February 9, 1998)
  • K974478 — IMMUNO CONCEPTS ANCA TEST SYSTEMS (February 9, 1998)
  • K955602 — RELSIA SCL-70 ANTIBODY TEST SYSTEM (April 19, 1996)
  • K955605 — RELISA JO-1 ANTIBODY TEST SYSTEM (April 19, 1996)

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