Cleared Traditional

PLATELETWORKS, MODELS PW-A, PW-C

K023761 · Helena Laboratories · Hematology
Feb 2003
Decision
98d
Days
Class 2
Risk

About This 510(k) Submission

K023761 is an FDA 510(k) clearance for the PLATELETWORKS, MODELS PW-A, PW-C, 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 February 14, 2003, 98 days after receiving the submission on November 8, 2002. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5700.

Submission Details

510(k) Number K023761 FDA.gov
FDA Decision Cleared SESE
Date Received November 08, 2002
Decision Date February 14, 2003
Days to Decision 98 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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