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FDA 510(k)

Citrated: K, KH, RTH, FFH

K-Number: K232018 · 2024-03-29

ApplicantHaemonetics Corporation
Decision Date2024-03-29
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

Citrated: K, KH, RTH, FFH is the device name listed in this FDA 510(k) record. The listed applicant is Haemonetics Corporation. It received FDA 510(k) clearance on 2024-03-29 under 510(k) number K232018. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Citrated: K, KH, RTH, FFH?

Citrated: K, KH, RTH, FFH is a medical device that received FDA 510(k) clearance on 2024-03-29. The listed applicant is Haemonetics Corporation. The 510(k) number is K232018.

When did Citrated: K, KH, RTH, FFH receive FDA 510(k) clearance?

Citrated: K, KH, RTH, FFH received FDA 510(k) clearance on 2024-03-29, under 510(k) number K232018.

Who is the listed applicant for Citrated: K, KH, RTH, FFH?

The FDA 510(k) record lists Haemonetics Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Citrated: K, KH, RTH, FFH?

The FDA product code for Citrated: K, KH, RTH, FFH is JPA.

Other records listing Haemonetics Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251024TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeK243858TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeK221722Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)K183160TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay CartridgeK160502TEG 6s Hemostasis SystemK162423Haemonetics Cell Saver Elite/Elite+ Autotransfusion System

View all 8 devices →

Related Devices (Code: JPA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253658STA Satellite Max®Diagnostica Stago, Inc.K250965Automated Blood Coagulation Analyzer CN-Series (CN-6000)Sysmex America, Inc.K251024TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeHaemoneticsK243858TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeHaemonetics CorporationK233790ACL TOP 970 CLInstrumentation LaboratoryK221359ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMInstrumentation Laboratory CO

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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