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510(k) K141655

QUANTA FLASH RO52, QUANTA FLASH RO52 CALIBRATORS, AND QUANTA FLASH RO52 CONTROLS by Inova Diagnostics, Inc. — Product Code OBE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 2015
Date Received
June 20, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Anti-Ss-A 52 Autoantibodies
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

The device is used for the detection, in human serum or plasma, of autoantibodies to SS-A 52. The detection of SS-A 52 autoantibodies may aid in the diagnosis of systemic lupus erythematosus, Sjogren's syndrome, systemic sclerosis, polymyositis and dermatomyositis.

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Other clearances for product code OBE

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