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510(k) K010558

QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISA by Inova Diagnostics, Inc. — Product Code MLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 2001
Date Received
February 26, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control
Device Class
Class II
Regulation Number
866.5110
Review Panel
IM
Submission Type

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Other clearances for product code MLE

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