Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008382976

FEI Number

3008382976

Entity Name

Biochrom US

City/State/Country

Holliston, MA, US

Establishment Address

84 October Hill Rd Ste 10, Holliston, MA 01746, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

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
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

No US Agent registered (Local establishment).

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
3003521949	BIOCHROM LTD	CAMBRIDGE Cambridgeshire, GB

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.

Similar Registrations

Registration Number	Establishment Name	Location
3003795116	ROCHE DIAGNOSTICS INTERNATIONAL LTD.	ROTKREUZ Zug, CH
2244900	GLOBE SCIENTIFIC, LLC	Mahwah, NJ, US
3010194621	LABOTEK GROUP CORP	Bayamon, PR, US
2182595	DIASORIN INC.	Stillwater, MN, US
9610240	DiaSorin Italia S.p.A.	SALUGGIA Vercelli, IT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008382976. Last updated year: 2026. Please use registration number 3008382976 when referencing this establishment in official correspondence.