Data / Medical devices / United States / Haemonetics Corporation

Haemonetics Corporation: FDA-registered device maker in Clinton, PA, United States, 10 510(k) clearances

Name: Haemonetics Corporation FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Haemonetics Corporation is registered with the FDA (registration 3019849102) in Clinton, PA, United States. It lists 7 device types. The FDA files 10 510(k) clearances under its listings, the newest dated April 30, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3019849102
Address: 1300 Clifford Ball Drive, Clinton, PA, United States, 15026
Owner or operator: Haemonetics Corporation (1219343)
Roles: Manufacturer, Manufacturer for export
First device listed: December 11, 2007
Registered through: 2026
Brand names listed: Antiplatelet Reagent, NexSys PCS, Express Plus, PCS 300, NexSys PCS, PCS2, PCS 300, NexSys PCS, PlateletMapping, RapidTeg TEG-ACT Test, TEG 5000, TEG 5000 Analyzer and more

Devices it lists

Device	Product code	Class	Role	Source
Activated Whole Blood Clotting Time	JBP	2	Manufacturer	accessdata.fda.gov
Container, Empty, For Collection & Processing Of Blood & Blood Components	KSR	2	Manufacturer	accessdata.fda.gov
General Purpose Reagent	PPM	1	Manufacturer, Manufacturer for export	accessdata.fda.gov
Plasma, Coagulation Control	GGN	2	Manufacturer	accessdata.fda.gov
Separator, Automated, Blood Cell, Diagnostic	GKT	2	Manufacturer	accessdata.fda.gov
System, Automated Platelet Aggregation	JOZ	2	Manufacturer, Manufacturer for export	accessdata.fda.gov
System, Multipurpose For In Vitro Coagulation Studies	JPA	2	Manufacturer, Manufacturer for export	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 30, 2025	K251024	TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge	JPA	Substantially Equivalent	Haemonetics	accessdata.fda.gov
January 15, 2025	K243858	TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge	JPA	Substantially Equivalent	Haemonetics Corporation	accessdata.fda.gov
March 29, 2024	K232018	Citrated: K, KH, RTH, FFH	JPA	Substantially Equivalent	Haemonetics Corporation	accessdata.fda.gov
May 9, 2019	K183160	TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge	JPA	Substantially Equivalent	Haemonetics Corporation	accessdata.fda.gov
June 26, 2015	K150041	CORA (Coagulation Resonance Analysis) System	JPA	Substantially Equivalent	Coramed Technologies, LLC	accessdata.fda.gov
January 3, 2015	K140893	CORA (COAGULATION RESONANCE ANALYSIS) SYSTEM WITH PLATELET MAPPING ASSAY	JOZ	Substantially Equivalent	Coramed Technologies, LLC	accessdata.fda.gov
January 31, 2007	K062604	RAPIDTEG TEG-ACT TEST	JBP	Substantially Equivalent	Haemoscope Corp.	accessdata.fda.gov
September 1, 2004	K041502	THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY	JOZ	Substantially Equivalent	Haemoscope Corp.	accessdata.fda.gov
September 14, 2000	K002177	THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIES	JPA	Substantially Equivalent	Haemoscope Corp.	accessdata.fda.gov
May 5, 2000	K993678	THROMBELASTOGRAPH COAGULATION ANALYZER TEG - 5000 SERIES	JPA	Substantially Equivalent	Haemoscope Corp.	accessdata.fda.gov

Compare with other makers

Updated April 30, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.