Cleared Traditional

ACCUMETRICS,INC. VERIFYNOW PRUTEST, ACCUMETRICS, INC. VERIFYNOW PRUTEST

K141427 · Accumetrics, Inc. · Hematology
Jul 2015
Decision
420d
Days
Class 2
Risk

About This 510(k) Submission

K141427 is an FDA 510(k) clearance for the ACCUMETRICS,INC. VERIFYNOW PRUTEST, ACCUMETRICS, INC. VERIFYNOW PRUTEST, 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 July 24, 2015, 420 days after receiving the submission on May 30, 2014. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5700.

Submission Details

510(k) Number K141427 FDA.gov
FDA Decision Cleared SESE
Date Received May 30, 2014
Decision Date July 24, 2015
Days to Decision 420 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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