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510(k) K984619

BINDING SITE BINDAZYME ANTI-GBM EIA DIAGNOSTIC TEST KIT by The Binding Site, Ltd. — Product Code MVJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 1999
Date Received
December 29, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)
Device Class
Class II
Regulation Number
866.5660
Review Panel
IM
Submission Type

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Other clearances for product code MVJ

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