Cleared Traditional

THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY

K041502 · Haemoscope Corp. · Hematology
Sep 2004
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K041502 is an FDA 510(k) clearance for the THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY, a System, Automated Platelet Aggregation (Class II — Special Controls, product code JOZ), submitted by Haemoscope Corp. (Niles, US). The FDA issued a Cleared decision on September 1, 2004, 86 days after receiving the submission on June 7, 2004. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5700.

Submission Details

510(k) Number K041502 FDA.gov
FDA Decision Cleared SESE
Date Received June 07, 2004
Decision Date September 01, 2004
Days to Decision 86 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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