Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003521949

FEI Number

3003521949

Entity Name

BIOCHROM LTD

City/State/Country

CAMBRIDGE Cambridgeshire, GB

Establishment Address

Unit 7, Enterprise Zone, 3970 Cambridge Research Park,Beach Drive,, Waterbeach, CAMBRIDGE Cambridgeshire CB25 9PE, GB

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Harvard Bioscience Inc (Owner Number: 9079679)

Owner / Operator Contact Address

84 October Hill Road, Suite 10, Holliston, MA 01746, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MVU	Reagents, Specific, Analyte	Pathology	Class 1	864.4020	2020-01-24
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2020-01-24
JJF	Analyzer, Chemistry, Micro, For Clinical Use	Clinical Chemistry	Class 1	862.2170	2008-01-04

Official Correspondent

No official correspondent registered.

US Agent Details

Robert Wales Email: Rwales@harvardbioscience.com Phone: (508) 8938999

Related Public Records

Same Entity

Harvard Bioscience Inc

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3008382976	Biochrom US	Holliston, MA, US

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0038-2020	Vital Scientific N.V. 24, Kanaalweg Postbus 100 Dieren Netherlands	1	V-Twin, Catalog # 6002-800, UDI: 03661540600180 - Product Usage: An in vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry, monitoring drugs of abuse and in therapeutic drug monitoring.

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3004375571	GLYCOMINDS DIAGNOSTICS (2014) LTD.	Raanana Central, IL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003521949. Last updated year: 2026. Please use registration number 3003521949 when referencing this establishment in official correspondence.