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510(k) K992528

BIOCHECK IGE ELISA, MODEL BC-1035 by Biocheck, Inc. — Product Code DGC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 1999
Date Received
July 28, 1999
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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