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510(k) K843181

AUTOFLUOR IV SYSTEM by Tech America Diagnostics — Product Code DBM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 1984
Date Received
August 13, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
Device Class
Class II
Regulation Number
866.5090
Review Panel
IM
Submission Type

Other clearances by Tech America Diagnostics

  • K842991 — AUTOFLUOR V SYSTEM (March 14, 1985)
  • K841984 — AUTOFLOUR III SYSTEM (November 1, 1984)

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