Cleared Traditional

VERIFYNOW-P2Y12 ASSAY

K051231 · Accumetrics, Inc. · Hematology
Aug 2005
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K051231 is an FDA 510(k) clearance for the VERIFYNOW-P2Y12 ASSAY, a System, Automated Platelet Aggregation (Class II — Special Controls, product code JOZ), submitted by Accumetrics, Inc. (San Diego, US). The FDA issued a Cleared decision on August 5, 2005, 84 days after receiving the submission on May 13, 2005. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5700.

Submission Details

510(k) Number K051231 FDA.gov
FDA Decision Cleared SESE
Date Received May 13, 2005
Decision Date August 05, 2005
Days to Decision 84 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code JOZ — System, Automated Platelet Aggregation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5700

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