Medical Device Manufacturer · US , Santa Maria , CA

Hardy Diagnostics - FDA 510(k) Cleared Devices

109 submissions · 109 cleared · Since 1993

Recent clearances: HardyDisk AST Gepotidacin 10µg (GEP10), HardyDisk AST Cefiderocol 30µg (FDC30), HardyDisk AST Gepotidacin 10µg (GEP10)

109

Total

109

Cleared

Denied

Hardy Diagnostics is an American health care company headquartered in Santa Maria, California. The company manufactures bacteriological culture media, reagents, automated microscope slide staining machines, and rapid identification kits for microbiological testing.

Hardy Diagnostics has received 109 FDA 510(k) clearances from 109 total submissions since 1993. The company specializes exclusively in Microbiology devices, with its most recent clearance in 2025. Recent cleared devices include antibiotic susceptibility testing disks and viral transport media.

The company manufactures more than 2,700 different media products for detecting bacterial pathogens including Salmonella, Listeria, E. coli, Tuberculosis, Staphylococcus, Streptococcus, and Legionella. Hardy Diagnostics operates three manufacturing facilities across the United States and acquired a microscope slide stainer manufacturer in Texas in 2016.

Explore the complete regulatory record, including device names, product codes, and clearance dates in the database below.

5 submissions have an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.

Hardy Diagnostics is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.