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510(k) K981237

QUANTA LITE RIBOSOME P ELISA by Inova Diagnostics, Inc. — Product Code MQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 1998
Date Received
April 3, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Anti-Ribosomal P Antibodies
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

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