HAEMONETICS CORPORATION

FDA Device Registration & Listing · Boston, MA, US · Registration 1219343

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
1219343
FEI Number
1219343
Entity Name
HAEMONETICS CORPORATION
City/State/Country
Boston, MA, US
Establishment Address
125 Summer Street, Boston, MA 02110, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
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
BK870026
PMA Number
N/A

All Registered Proprietary Names

PCS 2 Plasma Collection System, Wireless (W) Capable Modification TEG 6s Haemonetics Model 215 Automated Glycerolization/Deglycerolization and Cell Washing System ACP215 TEG 5000 R.I.S. TEG 6s Cell Saver Elite PCS2 Plasma Collection System MCS+ 9000 System SafeTrace Tx PCS2, PCS 300, NexSys PCS Cell Saver 5 PlateletMapping MCS+LN8150 Cell Saver Elite Leukotrap Cell Saver 5, Cell Saver 5+ Cell Saver Elite NextGen 3 NexLynk DMS ACP215 Cell Saver Elite+ NexLynk DMS PCS2, PCS 300, NexSys PCS TEG 5000 Analyzer TEG 6s PCS2 SafeTrace Tx TEG 6s QC Antiplatelet Reagent TEG Manager TEG 6s InstaMatch 1 MCS+8150 Apheresis System Cell Saver Elite ACP215 SafeTrace Tx 3.12 Cymbal PCS2 NexSys PCS

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2010-04-30
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
KSW System, Processing For Frozen Blood Hematology Class 2 864.9145 2008-11-06
JPA System, Multipurpose For In Vitro Coagulation Studies Hematology Class 2 864.5425 2013-01-15
FRN Pump, Infusion General Hospital Class 2 880.5725 2015-08-20
JPA System, Multipurpose For In Vitro Coagulation Studies Hematology Class 2 864.5425 2025-06-04
CAC Apparatus, Autotransfusion Anesthesiology Class 2 868.5830 2017-01-04
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2010-04-30
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2010-04-30
MMH Blood Establishment Computer Software And Accessories Hematology Class 2 864.9165 2025-09-18
KSR Container, Empty, For Collection & Processing Of Blood & Blood Components Hematology Class 2 864.9100 2009-10-20
CAC Apparatus, Autotransfusion Anesthesiology Class 2 868.5830 2008-11-06
JOZ System, Automated Platelet Aggregation Hematology Class 2 864.5700 2007-12-11
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2010-05-03
CAC Apparatus, Autotransfusion Anesthesiology Class 2 868.5830 2011-01-24
KST System, Blood Collection, Vacuum-Assisted, Manual Hematology Class 1 864.9125 2020-02-24
CAC Apparatus, Autotransfusion Anesthesiology Class 2 868.5830 2014-01-16
MMH Blood Establishment Computer Software And Accessories Hematology Class 2 864.9165 2016-10-18
KSW System, Processing For Frozen Blood Hematology Class 2 864.9145 2010-05-03
CAC Apparatus, Autotransfusion Anesthesiology Class 2 868.5830 2023-10-18
MMH Blood Establishment Computer Software And Accessories Hematology Class 2 864.9165 2024-04-10
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2013-11-12
JPA System, Multipurpose For In Vitro Coagulation Studies Hematology Class 2 864.5425 2007-12-11
JOZ System, Automated Platelet Aggregation Hematology Class 2 864.5700 2015-03-13
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2013-11-12
MMH Blood Establishment Computer Software And Accessories Hematology Class 2 864.9165 2012-08-15
GGN Plasma, Coagulation Control Hematology Class 2 864.5425 2018-09-20
PPM General Purpose Reagent Pathology Class 1 864.4010 2025-05-13
OUG Medical Device Data System General Hospital Class 1 880.6310 2019-02-07
JPA System, Multipurpose For In Vitro Coagulation Studies Hematology Class 2 864.5425 2025-06-04
MMH Blood Establishment Computer Software And Accessories Hematology Class 2 864.9165 2016-10-18
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2010-06-17
CAC Apparatus, Autotransfusion Anesthesiology Class 2 868.5830 2012-09-25
KSW System, Processing For Frozen Blood Hematology Class 2 864.9145 2010-04-30
MMH Blood Establishment Computer Software And Accessories Hematology Class 2 864.9165 2016-10-18
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2011-01-24
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2014-01-09

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
3019849102 Haemonetics Corporation Clinton, PA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
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
K924453 Organon Teknika Corp. MULTI-CHANNEL DISCRETE ANALYZER (MDA-180) 1992-12-18
K913718 Abbott Laboratories PANCRETEC I.V. MODEL 5000 INFUS DEVICE, MODIFIED 1991-10-30

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-0514-2014 Instrumentation Laboratory Co. 2
HemosIL Normal Control 1 UNASSAYED Part Number: 0020003120
Z-0515-2014 Instrumentation Laboratory Co. 2
HemosIL Low Abnormal Control 2 UNASSAYED Part Number: 0020003220
Z-0516-2014 Instrumentation Laboratory Co. 2
HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320
Z-0032-06 BIOMERIEUX, INC. 2
VeriCal Calibrator Set

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1219343. Last updated year: 2026. Please use registration number 1219343 when referencing this establishment in official correspondence.
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