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510(k) K905386

DISTAT ANTI-DSDNA KIT by Shield Diagnostics, Ltd. — Product Code KTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 1990
Date Received
November 30, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Anti-Dna Indirect Immunofluorescent Solid Phase
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

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  • K951487 — DIASTAT ANTI-THYROID PEROXIDASE KIT (June 30, 1995)
  • K952183 — DIASTAT ANTI-THYROGLOBULIN KIT (June 30, 1995)

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