Home / 510(k) Clearances / K141210

510(k) K141210

QUANTA FLASH SS-B, QUANTA FLASH SS-B CALIBRATORS, AND QUANTA FLASH SS-B CONTROLS by Inova Diagnostics, Inc. — Product Code LLL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 2015
Date Received
May 9, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Extractable Antinuclear Antibody, Antigen And Control
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

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  • K142781 — ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody (March 31, 2015)
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