Cleared Traditional

QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1, HemosIL AcuStar Anti-B2GPI Domain 1 Controls

K152875 · Inova Diagnostics, Inc. · Immunology
Dec 2015
Decision
82d
Days
Class 2
Risk

About This 510(k) Submission

K152875 is an FDA 510(k) clearance for the QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1, HemosIL AcuStar Anti-B2GPI Domain 1 Controls, a System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) (Class II — Special Controls, product code MSV), submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on December 21, 2015, 82 days after receiving the submission on September 30, 2015. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K152875 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2015
Decision Date December 21, 2015
Days to Decision 82 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code MSV — System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5660

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