Data / Medical devices / Canada / Diagnostics Biochem Canada, Inc.

Diagnostics Biochem Canada, Inc.: FDA-registered device maker in London Ontario, Canada, 2 510(k) clearances

Name: Diagnostics Biochem Canada, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Diagnostics Biochem Canada, Inc. is registered with the FDA (registration 8010132) in London Ontario, Canada. It lists 16 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 18, 2003. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 8010132
FEI number: 3002806808
Address: 384 Neptune Crescent, London Ontario, Canada, N6M 1A1
Owner or operator: DIAGNOSTICS BIOCHEM CANADA, INC. (8010132)
Roles: Manufacturer
First device listed: December 9, 1977
Registered through: 2026
Brand names listed: 17?-Hydroxyprogesterone (17?-OHP) ELISA (CAN-P-320), 17?-Hydroxyprogesterone (17?-OHP) ELISA (CAN-P-400), 17?-Hydroxyprogesterone (17?-OHP) ELISA (CAN-P-540), Androstenedione ELISA (CAN-AD-208), Dehydroepiandrosterone (DHEA) ELISA (CAN-DH-490), Dehydroepiandrosterone Sulfate (DHEAS) ELISA (CAN-DHS-480), Estradiol ELISA (CAN-E-430), Estrone ELISA (CAN-E-420, CAN-E-420-8PK) and more

Devices it lists

Device	Product code	Class	Role	Source
Radioimmunoassay, 17-Hydroxyprogesterone	JLX	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Androstenedione	CIZ	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)	JKC	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Estradiol	CHP	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Estriol	CGI	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Estrone	CGF	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Follicle-Stimulating Hormone	CGJ	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Glucagon	JME	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Human Growth Hormone	CFL	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Luteinizing Hormone	CEP	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Pregnenolone	JNG	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Progesterone	JLS	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Prolactin (Lactogen)	CFT	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Testosterones And Dihydrotestosterone	CDZ	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Total Estrogens, Nonpregnancy	JMD	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Total Triiodothyronine	CDP	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 18, 2003	K030730	FREE TESTOSTERONE ENZYMEIMMUNOASSAY (EIA) KIT	CDZ	Substantially Equivalent	Diagnostics Biochem Canada, Inc.	accessdata.fda.gov
February 8, 2002	K014120	TESTOSTERONE BY ENZYMEIMMUNOASSAY (EIA)	CDZ	Substantially Equivalent	Diagnostics Biochem Canada, Inc.	accessdata.fda.gov

Compare with other makers

Updated August 18, 2003. 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.