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510(k) K830652

ANTI N DNA-HCP by Immuno-Products Industries — Product Code KTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 1983
Date Received
March 7, 1983
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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  • K810984 — ANTIMITOCHONDRIAL IMMUNOFLUORESCENT TEST (May 1, 1981)

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