Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9681721

FEI Number

3000264242

Entity Name

BIOHIT OYJ

City/State/Country

HELSINKI Uusimaa, FI

Establishment Address

LAIPPATIE 1, HELSINKI Uusimaa FI-00880, FI

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Biohit Oyj (Owner Number: 9026615)

Owner / Operator Contact Address

Laippatie 1, Helsinki, FI-18 FI-00880, FI

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

GASTRIN-17 ADVANCED ELISA TEST GASTRIN-17 ELISA TEST

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CGC	Radioimmunoassay, Gastrin	Clinical Chemistry	Class 1	862.1325	2005-07-12

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Biohit Oyj

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
K831075	United Diagnostics, Inc.	BLOOD GAS & FLAME PHOTOMETER INSTRU-	1983-06-22

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2419955	MP BIOMEDICALS DIAGNOSTICS DIVISION	Solon, OH, US
1520597	CRESCENT MFG. CO.	FREMONT, OH, US
3044467533	TAROMED INC	Los Angeles, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9681721. Last updated year: 2026. Please use registration number 9681721 when referencing this establishment in official correspondence.