Cleared Special

VERIFYNOW-ASPIRIN ASSAY

K042423 · Accumetrics, Inc. · Hematology
Oct 2004
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K042423 is an FDA 510(k) clearance for the VERIFYNOW-ASPIRIN 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 October 6, 2004, 29 days after receiving the submission on September 7, 2004. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5700.

Submission Details

510(k) Number K042423 FDA.gov
FDA Decision Cleared SESE
Date Received September 07, 2004
Decision Date October 06, 2004
Days to Decision 29 days
Submission Type Special
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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