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510(k) K862821

CAPPEL DIAGNOSTICS ANA KIT by Cappel Diagnostics, Inc. — Product Code DHN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 1986
Date Received
July 25, 1986
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 Cappel Diagnostics, Inc.

  • K872839 — ANTINUCLEAR ANTIBODY TEST (October 20, 1987)
  • K864275 — ANTI-NDNA ANTIBODY TEST KIT (December 15, 1986)

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