HiArc

FDA Device Registration & Listing · Merrimack, NH, US · Registration 1219738

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
1219738
FEI Number
1219738
Entity Name
HiArc
City/State/Country
Merrimack, NH, US
Establishment Address
220 DANIEL WEBSTER HWY., Merrimack, NH 03054, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
KMC Systems (Owner Number: 9024188)
Owner / Operator Contact Address
220 DANIEL WEBSTER HWY., --, Merrimack, NH 03054, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

ACUSTAR

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GGN Plasma, Coagulation Control Hematology Class 2 864.5425 2013-02-06
DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control Hematology Class 2 864.7320 2013-02-06
JPA System, Multipurpose For In Vitro Coagulation Studies Hematology Class 2 864.5425 2013-02-06

Official Correspondent

Andrew Sageman

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

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

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
K151534 Instrumentation Laboratory CO HemosIL D-Dimer HS 2015-07-06
K160885 Instrumentation Laboratory CO HemosIL D-Dimer HS 2016-10-27

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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
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.

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3005792925 TEM Innovations GmbH Munich Bavaria, DE
3037000637 INSTRUMENTATION LABORATORY CO. - Devens Devens, MA, US
2184009 MEDTRONIC PERFUSION SYSTEMS Minneapolis, MN, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1219738. Last updated year: 2026. Please use registration number 1219738 when referencing this establishment in official correspondence.
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