Cleared Traditional

Citrated: K, KH, RTH, FFH

K232018 · Haemonetics Corporation · Hematology
Mar 2024
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K232018 is an FDA 510(k) clearance for the Citrated: K, KH, RTH, FFH, a System, Multipurpose For In Vitro Coagulation Studies (Class II — Special Controls, product code JPA), submitted by Haemonetics Corporation (Boston, US). The FDA issued a Cleared decision on March 29, 2024, 266 days after receiving the submission on July 7, 2023. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K232018 FDA.gov
FDA Decision Cleared SESE
Date Received July 07, 2023
Decision Date March 29, 2024
Days to Decision 266 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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