Haemonetics Corporation

FDA Device Registration & Listing · Clinton, PA, US · Registration 3019849102

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3019849102
FEI Number
3019849102
Entity Name
Haemonetics Corporation
City/State/Country
Clinton, PA, US
Establishment Address
1300 Clifford Ball Drive, Clinton, PA 15026, US
Establishment Type(s)
Manufacture Device in the United States for Export Only
Owner / Operator
Haemonetics Corporation (Owner Number: 1219343)
Owner / Operator Contact Address
125 Summer St, Boston, MA 02110, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

RapidTeg TEG-ACT Test PCS 300, NexSys PCS TEG 6s TEG 6s QC TEG 5000 Analyzer Antiplatelet Reagent Antiplatelet Reagent PCS2, PCS 300, NexSys PCS PCS2, PCS 300, NexSys PCS TEG 6s TEG 6s TEG 6s TEG 6s TEG 6s TEG 6s

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JBP Activated Whole Blood Clotting Time Hematology Class 2 864.7140 2007-12-11
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2018-08-22
JPA System, Multipurpose For In Vitro Coagulation Studies Hematology Class 2 864.5425 2025-06-04
GGN Plasma, Coagulation Control Hematology Class 2 864.5425 2018-09-20
JPA System, Multipurpose For In Vitro Coagulation Studies Hematology Class 2 864.5425 2007-12-11
PPM General Purpose Reagent Pathology Class 1 864.4010 2025-05-13
PPM General Purpose Reagent Pathology Class 1 864.4010 2025-05-13
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2013-11-12
KSR Container, Empty, For Collection & Processing Of Blood & Blood Components Hematology Class 2 864.9100 2009-10-20
JPA System, Multipurpose For In Vitro Coagulation Studies Hematology Class 2 864.5425 2021-03-03
GGN Plasma, Coagulation Control Hematology Class 2 864.5425 2019-06-18
JPA System, Multipurpose For In Vitro Coagulation Studies Hematology Class 2 864.5425 2019-06-18
JOZ System, Automated Platelet Aggregation Hematology Class 2 864.5700 2015-03-13
JPA System, Multipurpose For In Vitro Coagulation Studies Hematology Class 2 864.5425 2015-07-15
JPA System, Multipurpose For In Vitro Coagulation Studies Hematology Class 2 864.5425 2025-06-04
JOZ System, Automated Platelet Aggregation Hematology Class 2 864.5700 2021-03-03

Official Correspondent

Julie Ryan

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Haemonetics Corporation
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3011773324 Haemonetics Corporation Salt Lake City, UT, US
3011538588 Haemonetics Malaysia Sdn Bhd Penang Pulau Pinang, MY
9617787 Haemonetics Mexico Manufacturing S. de R.L. de C.V. TIJUANA, B.C. Mexico, MX
1219343 HAEMONETICS CORPORATION Boston, MA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K924453 Organon Teknika Corp. MULTI-CHANNEL DISCRETE ANALYZER (MDA-180) 1992-12-18
K021022 Instrumentation Laboratory CO HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED); HEMOSIL LOW ABNORMAL CONTROL 2 (UNASSAYED) 2002-05-14
K113211 Instrumentation Laboratory CO HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL 2012-01-04
K082859 Instrumentation Laboratory CO HEMOSIL ROUTINE CONTROL LEVEL 1, LEVEL 2, LEVEL 3 UNASSAYED 2008-12-19

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0035-2007 Haemonetics Corporation 2
SmartSuction Harmony Powered Suction Device Model Number: HAR-E-115-US
Z-0032-06 BIOMERIEUX, INC. 2
VeriCal Calibrator Set
Z-0042-05 Dade Behring Inc. Rte 896, Glasgow Business Community 2
DispoSystem for BCT System.Model number OVFR03. Multipurpose System for in vitro coagulation studies.
Z-0043-05 bioMerieux 2
The MDA system with MDA Antithrombin III MDA Heparin
Z-0736-04 Instrumentation Laboratory Co. 2
ACL Futura Instrument Analyzer

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3019849102. Last updated year: 2026. Please use registration number 3019849102 when referencing this establishment in official correspondence.
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