Home / 510(k) Clearances / K993839

510(k) K993839

ENA PROFILE ELISA TEST SYSTEM by Trinity Biotech USA — Product Code LLL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 2000
Date Received
November 12, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Extractable Antinuclear Antibody, Antigen And Control
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

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