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510(k) K841984

AUTOFLOUR III SYSTEM by Tech America Diagnostics — Product Code DHN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 1984
Date Received
May 15, 1984
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 Tech America Diagnostics

  • K842991 — AUTOFLUOR V SYSTEM (March 14, 1985)
  • K843181 — AUTOFLUOR IV SYSTEM (September 17, 1984)

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