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510(k) K864275

ANTI-NDNA ANTIBODY TEST KIT by Cappel Diagnostics, Inc. — Product Code KTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 1986
Date Received
October 29, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Anti-Dna Indirect Immunofluorescent Solid Phase
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)
  • K862821 — CAPPEL DIAGNOSTICS ANA KIT (August 15, 1986)

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