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510(k) K034057

LACRYTEST by Adiatec SA — Product Code DGC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 2004
Date Received
December 30, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ige, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
Submission Type

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