Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017877290

FEI Number

3017877290

Entity Name

APOLLO BIOTECH CO., LTD.

City/State/Country

New Taipei City, TW

Establishment Address

18F-1 No. 75 Xintai 5th Road, Xizhi 22101, New Taipei City 22101, TW

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Apollo BioTech co., ltd. (Owner Number: 10082148)

Owner / Operator Contact Address

18F-1 No. 75 Xintai 5th Road, Xizhi 22101, New Taipei City, TW-NWT 22101, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

assaya iaX-2101 assaya intelligent analyzer eXpress-2101 Apollo BioTech iaX-2101

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JJQ	Colorimeter, Photometer, Spectrophotometer For Clinical Use	Clinical Chemistry	Class 1	862.2300	2021-06-20

Official Correspondent

Abri-Elle Sivertsen

US Agent Details

Abri-Elle Sivertsen Business: Assaya LLC Email: ae@assaya.com Phone: (678) 2341775

Related Public Records

Same Entity

Apollo BioTech co., ltd.

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
K760232	Instrumentation Laboratory CO	PRINTER, IL 460	1976-08-26

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3010399798	Innokas Medical Estonia Ou	Tallinn Harjumaa, EE
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9610806	Siemens Healthcare Diagnostics Products GmbH	MARBURG Hesse, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017877290. Last updated year: 2026. Please use registration number 3017877290 when referencing this establishment in official correspondence.