Data / Medical devices / Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use

Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use (JJC): 17 FDA-registered makers in 4 countries

Name: FDA-registered makers of Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

17 establishments in 4 countries are registered with the FDA to make Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use (product code JJC, Class 1, 21 CFR 862.2150). 2 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 32 510(k) clearances under this code, the latest on April 5, 1995, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.

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Product code: JJC
Device class: 1
Regulation: 862.2150
Medical specialty: Clinical Chemistry

Makers by country

Country	Makers
China	8
United States	5
India	3
Switzerland	1

Makers of Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Maker	Location	Role	510(k) clearances	Latest clearance	Source
Astoria-Pacific, Inc.	Clackamas, OR, United States	Manufacturer	1	February 17, 1989	api.fda.gov
Nova Biomedical Corporation	Waltham, MA, United States	Manufacturer, Remanufacturer	1	February 8, 1995	api.fda.gov
Accuster Technologies Pvt. Ltd.	New Delhi, India	Manufacturer	0		api.fda.gov
Aikang Medtech Co., Ltd	Shenzhen Guangdong, China	Manufacturer	0		api.fda.gov
Bioteke Corporation (wuxi) Co., Ltd	Wuxi City Jiangsu, China	Manufacturer	0		api.fda.gov
Caplugs, Inc.	Rancho Dominguez, CA, United States	Manufacturer	0		api.fda.gov
Dirui Industrial Co., Ltd.	CHANGCHUN Jilin, China	Manufacturer	0		api.fda.gov
Hamilton Bonaduz AG	BONADUZ Graubunden, Switzerland	Manufacturer	0		api.fda.gov
Infitek Co., Ltd.	Shanghai, China	Manufacturer	0		api.fda.gov
Labpeak Co.,ltd	Jinan Shandong, China	Exporter to the US, Manufacturer	0		api.fda.gov
Lords Mark Industries Ltd.	Daman and Diu Dadra and Nagar Haveli, India	Manufacturer	0		api.fda.gov
Q-Line Biotech Limited	Lucknow Uttar Pradesh, India	Manufacturer	0		api.fda.gov
Scitek Global Co.,ltd	Jinan Shandong, China	Exporter to the US, Manufacturer	0		api.fda.gov
Shenzhen Well Electric Co. Limited	Shenzhen Guangdong, China	Manufacturer	0		api.fda.gov
Siemens Healthcare Diagnostics Inc.	Tarrytown, NY, United States	Complaint file establishment, Specification developer	0		api.fda.gov
Siemens Healthcare Diagnostics Inc.	E Walpole, MA, United States	Manufacturer, Repackager or relabeler, Specification developer	0		api.fda.gov
Yantai Addcare Bio-Tech Co., Ltd.	Yantai Shandong, China	Contract manufacturer, Exporter to the US, Manufacturer	0		api.fda.gov

Updated April 5, 1995. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.