Cleared Traditional

PLATELETWORKS

K012723 · Helena Laboratories · Hematology
Sep 2001
Decision
44d
Days
Class 2
Risk

About This 510(k) Submission

K012723 is an FDA 510(k) clearance for the PLATELETWORKS, a System, Automated Platelet Aggregation (Class II — Special Controls, product code JOZ), submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on September 28, 2001, 44 days after receiving the submission on August 15, 2001. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5700.

Submission Details

510(k) Number K012723 FDA.gov
FDA Decision Cleared SESE
Date Received August 15, 2001
Decision Date September 28, 2001
Days to Decision 44 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

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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