Cleared Special

TEG 6s Hemostasis System

K160502 · Haemonetics Corporation · Hematology
Apr 2017
Decision
421d
Days
Class 2
Risk

About This 510(k) Submission

K160502 is an FDA 510(k) clearance for the TEG 6s Hemostasis System, a System, Multipurpose For In Vitro Coagulation Studies (Class II — Special Controls, product code JPA), submitted by Haemonetics Corporation (Braintree, US). The FDA issued a Cleared decision on April 19, 2017, 421 days after receiving the submission on February 23, 2016. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K160502 FDA.gov
FDA Decision Cleared SESE
Date Received February 23, 2016
Decision Date April 19, 2017
Days to Decision 421 days
Submission Type Special
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code JPA — System, Multipurpose For In Vitro Coagulation Studies
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5425

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