Cleared Traditional

TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge

K183160 · Haemonetics Corporation · Hematology
May 2019
Decision
175d
Days
Class 2
Risk

About This 510(k) Submission

K183160 is an FDA 510(k) clearance for the TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge, 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 May 9, 2019, 175 days after receiving the submission on November 15, 2018. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K183160 FDA.gov
FDA Decision Cleared SESE
Date Received November 15, 2018
Decision Date May 09, 2019
Days to Decision 175 days
Submission Type Traditional
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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