Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1000340866

FEI Number

1000340866

Entity Name

PENTAPHARM AG

City/State/Country

Aesch Basel-Landschaft, CH

Establishment Address

Dornacherstr. 112, Aesch Basel-Landschaft 4147, CH

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Pentapharm AG (Owner Number: 9083272)

Owner / Operator Contact Address

Dornacherstrasse 112, --, Aesch, CH-BL 4147, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K042760

PMA Number

N/A

All Registered Proprietary Names

PEFAKIT APC-R Factor V Leiden PEFAKIT APC-R Factor V Leiden Controls

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GGW	Test, Time, Partial Thromboplastin	Hematology	Class 2	864.7925	2006-02-22
GIZ	Plasma, Control, Normal	Hematology	Class 2	864.5425	2013-12-17
JPA	System, Multipurpose For In Vitro Coagulation Studies	Hematology	Class 2	864.5425	2013-12-17
GGC	Control, Plasma, Abnormal	Hematology	Class 2	864.5425	2013-12-17
JPA	System, Multipurpose For In Vitro Coagulation Studies	Hematology	Class 2	864.5425	2014-01-29
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2006-02-22

Official Correspondent

Vincent Muller

US Agent Details

Michael McGuire Business: Pentapharm LLC Email: Michael.McGuire@pentapharm.com Phone: (800) 7973850

Related Public Records

Same Entity

Pentapharm AG

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
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-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
Z-0737-04	Instrumentation Laboratory Co.	2	ACL Advance Instrument Analyzer

Similar Registrations

Registration Number	Establishment Name	Location
9710666	Diagnostica Stago - Taverny	Taverny Val-d'Oise, FR
2245451	DIAGNOSTICA STAGO, INC.	PARSIPPANY, NJ, US
1835316	R2 DIAGNOSTICS, INC.	SOUTH BEND, IN, US
3037000637	INSTRUMENTATION LABORATORY CO. - Devens	Devens, MA, US
2431530	INSTRUMENTATION LABORATORY CO.	ORANGEBURG, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1000340866. Last updated year: 2026. Please use registration number 1000340866 when referencing this establishment in official correspondence.