Data / Medical devices / United States / Hardy Diagnostics

Hardy Diagnostics: FDA-registered device maker in Springboro, OH, United States, 8 510(k) clearances

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

Hardy Diagnostics is registered with the FDA (registration 3009547954) in Springboro, OH, United States. It lists 21 device types. The FDA files 8 510(k) clearances under its listings, the newest dated August 2, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3009547954
Address: 429 S Pioneer Blvd, Springboro, OH, United States, 45066
Owner or operator: HARDY DIAGNOSTICS (2022807)
Roles: Contract manufacturer, Manufacturer, Manufacturer for export, Remanufacturer, Repackager or relabeler, Specification developer
First device listed: December 9, 1992
Registered through: 2026
Brand names listed: A8 for Mycoplasma, Acanthamoeba Broth, 5ml, Acetamide Agar Slant, Acetate Differential Slnt, Agar Deep, 1.5%, Alkaline Peptone Water, AnaeroGro Anaerobic PEA, AnaeroGro BBE Agar and more

Devices it lists

Device	Product code	Class	Role	Source
Basic Fuchsin	KKW	1	Repackager or relabeler	accessdata.fda.gov
Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar	JSO	2	Manufacturer	accessdata.fda.gov
Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth	JTZ	2	Contract manufacturer, Manufacturer, Manufacturer for export	accessdata.fda.gov
Culture Media, Enriched	KZI	1	Manufacturer	accessdata.fda.gov
Culture Media, For Isolation Of Pathogenic Neisseria	JTY	2	Manufacturer	accessdata.fda.gov
Culture Media, General Nutrient Broth	JSC	1	Manufacturer	accessdata.fda.gov
Culture Media, Multiple Biochemical Test	JSE	1	Manufacturer	accessdata.fda.gov
Culture Media, Non-Propagating Transport	JSM	1	Manufacturer	accessdata.fda.gov
Culture Media, Non-Selective And Differential	JSH	1	Manufacturer	accessdata.fda.gov
Culture Media, Non-Selective And Non-Differential	JSG	1	Manufacturer	accessdata.fda.gov
Culture Media, Selective And Differential	JSI	1	Manufacturer	accessdata.fda.gov
Culture Media, Selective And Non-Differential	JSJ	1	Manufacturer	accessdata.fda.gov
Culture Media, Selective Broth	JSD	1	Manufacturer	accessdata.fda.gov
Culture Media, Single Biochemical Test	JSF	1	Manufacturer	accessdata.fda.gov
Gbs Culture Media, Selective And Differential	PQZ	1	Manufacturer	accessdata.fda.gov
General Purpose Reagent	PPM	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Quality Control Slides	LJG	1	Repackager or relabeler	accessdata.fda.gov
Slide Stainer, Automated	KPA	1	Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Solution, Isotonic	JCE	1	Manufacturer	accessdata.fda.gov
Stains, Hematology	KQC	1	Repackager or relabeler	accessdata.fda.gov
Stains, Microbiologic	JTS	1	Repackager or relabeler	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 2, 2024	K233534	Viral Transport Medium	JSM	Substantially Equivalent	Hardy Diagnostics	accessdata.fda.gov
April 29, 2019	K190553	HardyCHROM CRE	JSO	Substantially Equivalent	Hardy Diagnostics	accessdata.fda.gov
March 22, 2018	K173903	Granada Medium	PQZ	Substantially Equivalent	Hardy Diagnostics	accessdata.fda.gov
May 22, 2017	K170586	Strep B Carrot Broth One-Step	PQZ	Substantially Equivalent	Hardy Diagnostics	accessdata.fda.gov
May 4, 2011	K102922	HARDYCHROM MRSA	JSO	Substantially Equivalent	Hardy Diagnostics	accessdata.fda.gov
October 16, 1995	K951754	CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST	JSO	Substantially Equivalent	Hardy Diagnostics	accessdata.fda.gov
July 6, 1982	K821602	THAYER MARTIN	JTY	Substantially Equivalent	Hardy Media	accessdata.fda.gov
July 2, 1981	K811646	MUELLER HINTON AGAR	JTZ	Substantially Equivalent	Hardy Media	accessdata.fda.gov

Compare with other makers

Updated August 2, 2024. 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.