Data / Medical devices / Device, Microtiter Diluting/Dispensing

Device, Microtiter Diluting/Dispensing (JTC): 19 FDA-registered makers in 9 countries

Name: FDA-registered makers of Device, Microtiter Diluting/Dispensing
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

19 establishments in 9 countries are registered with the FDA to make Device, Microtiter Diluting/Dispensing (product code JTC, Class 1, 21 CFR 866.2500). 2 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 66 510(k) clearances under this code, the latest on December 1, 1992, and lists 8 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code: JTC
Device class: 1
Regulation: 866.2500
Medical specialty: Microbiology

Makers by country

Country	Makers
United States	8
China	3
France	2
Netherlands	1
Singapore	1
Italy	1
South Korea	1
United Kingdom	1
Taiwan	1

Makers of Device, Microtiter Diluting/Dispensing

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	Recall events	Source
Diagnostic Automation/ Cortez Diagnostics Inc,.	Woodland Hills, CA, United States	Manufacturer	1	December 2, 1988	0	api.fda.gov
Remel, Inc.	Lenexa, KS, United States	Specification developer	1	July 21, 1980	0	api.fda.gov
BD Kiestra B.V.	Drachten Fryslan, Netherlands	Manufacturer, Specification developer	0		0	api.fda.gov
Beckman Coulter, Inc.	Miami, FL, United States	Contract manufacturer	0		0	api.fda.gov
Becton, Dickinson & Co.	Sparks, MD, United States	Complaint file establishment, Manufacturer	0		2	api.fda.gov
Bio-Rad	MARNES-LA-COQUETTE Ile-de-France, France	Specification developer	0		0	api.fda.gov
Biobase Biodustry(shandong)co., Ltd	Jinan Shandong, China	Manufacturer	0		0	api.fda.gov
Beckman Coulter, Inc.	West Sacramento, CA, United States	Specification developer	0		0	api.fda.gov
Bio-Rad Laboratories (Singapore) Pte. Ltd.	Singapore Central Singapore, Singapore	Contract manufacturer	0		0	api.fda.gov
Caplugs, Inc.	Rancho Dominguez, CA, United States	Manufacturer	0		0	api.fda.gov
Copan WASP	Brescia Lombardy, Italy	Manufacturer	0		0	api.fda.gov
Hamilton Co.	Reno, NV, United States	Contract manufacturer	0		4	api.fda.gov
MBD Co., Ltd.	Suwon-si Gyeonggi, South Korea	Manufacturer	0		0	api.fda.gov
PlasTAT Limited	Dongguan City Guangdong, China	Contract manufacturer	0		0	api.fda.gov
Plastikon Industries	Hayward, CA, United States	Contract manufacturer	0		0	api.fda.gov
Remel Europe Ltd	Dartford, Kent, United Kingdom	Contract manufacturer	0		0	api.fda.gov
Shanghai Kehua Laboratory System Co., Ltd.	Shanghai, China	Manufacturer	0		0	api.fda.gov
Tci Gene Inc.	Taipei, Taiwan	Manufacturer	0		0	api.fda.gov
Theradiag	MARNE LA VALLEE CEDEX 2 Seine-et-Marne, France	Manufacturer	0		0	api.fda.gov

Updated December 1, 1992. 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.