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510(k) K822607

ANTINUCLEAR ANTOBODY CELL SUBSTRATE by Immulok, Inc. — Product Code DHN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 1982
Date Received
August 27, 1982
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

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  • K823055 — FLOUROSET IMMUNOFLUORESCENT ANTIBODY (November 5, 1982)
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  • K822605 — TOXOPLASMA GONDII ANTIBODY IGG (October 27, 1982)
  • K821567 — IMMULOK CULTURESET (June 25, 1982)
  • K821411 — HISTOSET IMMUNOPEROFIDASE TISSUE (June 25, 1982)

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