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510(k) K801960

ANTI-DS/N-DNA TEST KIT by Immuno-Diagnostic Products, Inc. — Product Code DBL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 1980
Date Received
August 19, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
Device Class
Class II
Regulation Number
866.5660
Review Panel
IM
Submission Type

Other clearances by Immuno-Diagnostic Products, Inc.

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  • K801963 — CMV TEST KIT (October 23, 1980)
  • K801961 — RF-II TEST KIT (October 10, 1980)

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