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510(k) K811022

ANA TEST KIT by Immuno-Diagnostic Products, Inc. — Product Code DHN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1981
Date Received
April 15, 1981
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-Diagnostic Products, Inc.

  • K854207 — EBV(EPSTEIN-BARR VIRUS) TEST KIT (April 24, 1986)
  • K811021 — HERPES (November 5, 1981)
  • K811562 — TOXOPLASMOSIS TEST KIT (July 16, 1981)
  • K801959 — FTA-ABS TEST (October 23, 1980)
  • K801963 — CMV TEST KIT (October 23, 1980)
  • K801960 — ANTI-DS/N-DNA TEST KIT (October 10, 1980)
  • K801961 — RF-II TEST KIT (October 10, 1980)

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