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pro-lab incorporated: FDA-registered device maker in Richmond Hill Ontario, Canada, 1 510(k) clearance

Name: pro-lab incorporated FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

pro-lab incorporated is registered with the FDA (registration 8010383) in Richmond Hill Ontario, Canada. It lists 13 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 1, 1993. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 8010383
FEI number: 1000354384
Address: 20 Mural Street, Unit #4, Richmond Hill Ontario, Canada, L4B 1K3
Owner or operator: PRO-LAB, INC. (8010383)
Roles: Contract manufacturer, Exporter to the US, Manufacturer
First device listed: May 2, 1994
Registered through: 2026
Brand names listed: Agglut'n Cards (48)-ink circle, AmnioTest (100 pack), AmnioTest (20 Pack), AmnioTest Colour Cards, BD BBL Staphyloside Latex Test Kit (100 tests), BD BBL Staphyloside Latex Test Kit (500 tests), BD BBL Streptocard Acid Control +, BD BBL Streptocard Acid Extraction Reagent and more

Devices it lists

Device	Product code	Class	Role	Source
Antigens, All Types, Escherichia Coli	GMZ	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Antisera, All Groups, Salmonella Spp.	GRM	2	Exporter to the US	accessdata.fda.gov
Antisera, All Groups, Streptococcus Spp.	GTZ	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Antisera, All Types, Escherichia Coli	GNA	1	Manufacturer	accessdata.fda.gov
Antisera, All Types, Shigella Spp.	GNB	2	Exporter to the US	accessdata.fda.gov
Antisera, Fluorescent, All Types, Staphylococcus Spp.	GTN	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Crystal Violet For Histology	ICF	1	Exporter to the US	accessdata.fda.gov
Culture Media, Single Biochemical Test	JSF	1	Manufacturer	accessdata.fda.gov
Discs, Strips And Reagents, Microorganism Differentiation	JTO	1	Manufacturer	accessdata.fda.gov
Plasma, Coagulase, Human, Horse And Rabbit	JTL	1	Manufacturer	accessdata.fda.gov
Reagents, Antibody, Legionella, Direct & Indirect Fluorescent	LHL	2	Manufacturer	accessdata.fda.gov
Sampler, Amniotic Fluid (Amniocentesis Tray)	HIO	1	Manufacturer	accessdata.fda.gov
Supplement, Culture Media	JSK	1	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
September 1, 1993	K914419	AMNIOTEST(TM)	HIO	Substantially Equivalent	Pro-Lab, Inc.	accessdata.fda.gov

Compare with other makers

Updated September 1, 1993. 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.