Company · US
Hardy Diagnostics
FDA 510(k) clearances and medical device recalls filed under this name, 1993 to 2026. Name variants (Inc, Corp, punctuation) are merged.
110510(k) clearances (3 in 12 months)
20recalls (1 in 12 months)
6recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JTN | Susceptibility Test Discs, Antimicrobial | 85 |
| JSO | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar | 17 |
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | 10 |
| JSM | Culture Media, Non-Propagating Transport | 4 |
| PQZ | Gbs Culture Media, Selective And Differential | 4 |
| JTY | Culture Media, For Isolation Of Pathogenic Neisseria | 3 |
| KPA | Slide Stainer, Automated | 2 |
| JSC | Culture Media, General Nutrient Broth | 1 |
| JSI | Culture Media, Selective And Differential | 1 |
| JSJ | Culture Media, Selective And Non-Differential | 1 |
| JXC | Kit, Screening, Yeast | 1 |
| LKS | Device, Parasite Concentration | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 20, 2026 | K262113 | HardyDisk AST Tebipenem 10µg (TBP10) Hardy Diagnostics | JTN |
| May 11, 2026 | K260842 | HardyDisk AST Gepotidacin 10µg (GEP10) Hardy Diagnostics | JTN |
| Nov 20, 2025 | K253105 | HardyDisk AST Cefiderocol 30µg (FDC30) Hardy Diagnostics | JTN |
| Jun 26, 2025 | K250956 | HardyDisk AST Gepotidacin 10µg (GEP10) Hardy Diagnostics | JTN |
| May 15, 2025 | K250454 | HardyDisk Aztreonam/Avibactam 30/20µg (AZA50) Hardy Diagnostics | JTN |
| Aug 2, 2024 | K233534 | Viral Transport Medium Hardy Diagnostics | JSM |
| Jul 18, 2024 | K241060 | HardyDisk AST Cefiderocol 30µg (FDC30) Hardy Diagnostics | JTN |
| Jul 6, 2023 | K231568 | HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20) Hardy Diagnostics | JTN |
| Jun 1, 2023 | K230827 | HardyDisk AST Rezafungin 5µg (RZF5) Hardy Diagnostics | JTN |
| Jan 23, 2020 | K193504 | HardyDisk AST Cefiderocol 30ug (FDC30) Hardy Diagnostics | JTN |
| Sep 19, 2019 | K192326 | HardyDisk AST Lefamulin 20µg (LMU20) Hardy Diagnostics | JTN |
| Jul 31, 2019 | K191931 | HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25) Hardy Diagnostics | JTN |
| Apr 29, 2019 | K190553 | HardyCHROM CRE Hardy Diagnostics | JSO |
| Jan 18, 2019 | K183298 | HardyDisk AST Omadacycline 30µg (OMC30) Hardy Diagnostics | JTN |
| Sep 26, 2018 | K182357 | HardyDisk AST Eravacycline 20µg (ERV20) Hardy Diagnostics | JTN |
| Jul 10, 2018 | K181700 | HardyDisk AST Plazomicin 30ug (PLZ30) Hardy Diagnostics | JTN |
| Mar 22, 2018 | K173903 | Granada Medium Hardy Diagnostics | PQZ |
| Oct 3, 2017 | K172621 | HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30) Hardy Diagnostics | JTN |
| Aug 1, 2017 | K171975 | HardyDisk AST Delafloxacin 5 µg (DLX5) Hardy Diagnostics | JTN |
| May 22, 2017 | K170586 | Strep B Carrot Broth One-Step Hardy Diagnostics | PQZ |
| May 16, 2017 | K170481 | Strep B Carrot Broth Kit Hardy Diagnostics | PQZ |
| Mar 14, 2017 | K170127 | HardyDisk Ceftolozane/Tazobactam, (30/10 ug)-C/T40 Hardy Diagnostics | JTN |
| Nov 15, 2016 | K160512 | HardyCHROM ESBL Hardy Diagnostics | JSO |
| Nov 24, 2015 | K152846 | HardyDisk AST Ceftolozane/Tazobactam, (30/10ug)- C/T40 Hardy Diagnostics | JTN |
| Nov 24, 2015 | K152838 | HardyDisk AST Ceftazidime/Avibactam, (30/20ug)-CZA50 Hardy Diagnostics | JTN |
| May 4, 2011 | K102922 | HARDYCHROM MRSA Hardy Diagnostics | JSO |
| Dec 17, 2010 | K103538 | HARDYDISK AST CEFTAROLINE, 30 UG MODEL Z939 Hardy Diagnostics | JTN |
| Jan 8, 2010 | K093807 | HARDYDISK AST TELAVANCIN,30UG Hardy Diagnostics | JTN |
| Jan 29, 2008 | K080019 | HARDYDISK AST DORIPENEM 10 UG Hardy Diagnostics | JTN |
| Aug 23, 2006 | K062245 | HARDY DISK AST TIGECYCLINE 15 UG, MODELZ936 Hardy Diagnostics | JTN |
| Jun 13, 2001 | K011384 | HARDYDISK NOVOBIOCIN, 30MCG, MODEL Z883 Hardy Diagnostics | JTN |
| May 18, 2001 | K011385 | HARDKYDISK NEOMYCIN, 30 MCG Hardy Diagnostics | JTN |
| Apr 26, 2001 | K011086 | HARDYDISK BACITRACIN, 10MCG, MODEL Z927 Hardy Diagnostics | JTN |
| Jan 25, 2001 | K003690 | HARDYDISK SULFISOXAZOLE Hardy Diagnostics | JTN |
| Jan 19, 2001 | K003554 | HARDYDISK TRIMETHOPRIM 5MCG Hardy Diagnostics | JTN |
| Jan 17, 2001 | K003556 | HARDYDISK AMOXICILLIN/CLAVULANIC ACID, 20/10MCG Hardy Diagnostics | JTN |
| Jan 12, 2001 | K003686 | HARDYDISK TICARCILLIN/CLAVULANIC ACID, 85MCG Hardy Diagnostics | JTN |
| Jan 12, 2001 | K003537 | HARDYDISK RIFAMPIN, 5MCG Hardy Diagnostics | JTN |
| Jan 12, 2001 | K003536 | HARDYDISK NAFCILLIN, 1 MCG Hardy Diagnostics | JTN |
| Dec 13, 2000 | K003532 | HARDY DISK, CEFPODOXINE, 10MCG Hardy Diagnostics | JTN |
| Nov 2, 2000 | K002662 | HARDYDISK CLINDAMYCIN, 2MCG Hardy Diagnostics | JTN |
| Oct 26, 2000 | K002664 | HARDYDISK LEVOFLOXACIN, 5MCG Hardy Diagnostics | JTN |
| Oct 26, 2000 | K002661 | HARDYDISK CEFOTETAN, 30MCG Hardy Diagnostics | JTN |
| Oct 26, 2000 | K002660 | HARDYDISK LOMEFLOXACIN, 10MCG Hardy Diagnostics | JTN |
| Oct 26, 2000 | K002369 | HARDYDISK GENTAMICIN, 120MCG Hardy Diagnostics | JTN |
| Oct 26, 2000 | K002367 | HARDY DISK CEFTIZOXIME, 30MCG Hardy Diagnostics | JTN |
| Oct 25, 2000 | K002656 | HARDYDISK CEFUROXIME, 30MCG Hardy Diagnostics | JTN |
| Oct 25, 2000 | K002368 | HARDYDISK STREPTOMYCIN, 300MCG Hardy Diagnostics | JTN |
| Oct 19, 2000 | K002663 | HARDYDISK NETILMICIN, 30MCG Hardy Diagnostics | JTN |
| Jul 27, 2000 | K001728 | HARDY DISK CLARITHROMYCIN, 15MCG Hardy Diagnostics | JTN |
Newest 50 of 110.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 5, 2026 | Hardy Diagnostics HardyDisk AST Cefiderocol 30g (FDC30) REF Z9435
HardyDisk AST Cefiderocol 30g (FDC30) for in vitro agar diffusion susceptibility testing is indicated when there is the need to determine the suscepti Open, Classified |
JTN | K253105 |
| Jun 27, 2025 | Hardy Diagnostics HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No. G323 Open, Classified |
JSO | K190553 |
| Apr 16, 2021 | Hardy Diagnostics Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer. Terminated |
KPA | None listed |
| Dec 21, 2020 | Hardy Diagnostics Brain Heart Infusion Agar with 6 ug/ml Vancomycin Cat no: G14 Lot no: 472698 Manufactured: 2020-10-29 Expires: 2020-12-28 Container Type: 15x100mm plate, 18 ml Terminated |
JSO | K964560 |
| Oct 23, 2020 | Hardy Diagnostics Viral Transport Medium, 3ml, Ref: R99, Container type: Tube, Packaged: 20 tubes/box, IVD,
CVM Transport Media is provided in plastic centrifuge tubes and is used for the collection and transport of Terminated |
JSM | None listed |
| Oct 6, 2020 | Hardy Diagnostics Strep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499 Terminated |
PQZ | K170586 |
| Jun 9, 2020 | Hardy Diagnostics HardyCHROM MRSA,REF; G307, LOT: 447694, A selective and differential chromogenic medium for the qualitative direct detection of nasal colonization by methicillin-resistant Staphylococcus aureus (MRSA) Terminated |
JSO | K102922 |
| Jul 8, 2016 | Hardy Diagnostics QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80.
Systematically stains, rinses, decolorizes, and counter-stains the provided biological sample and slide. Terminated |
KPA | None listed |
| Mar 21, 2016 | Hardy Diagnostics Hardy Diagnostics GBS Detect
Cat no. A300.
Used for the isolation and detection by enhanced hemolysis of gamma-hemolytic (non-hemolytic) Group B Streptococcus. Terminated |
JSJ | None listed |
| Dec 23, 2015 | Hardy Diagnostics FB Broth, 10ml
(Fastidious Bacteria Broth)
Cat. no: K31 Lot: 15231
A fastidious bacteria broth for the enriched cultivation of Neisseria spp., Haemophilus spp., Streptococcus spp., Corynebacterium Terminated |
JSC | None listed |
| Aug 26, 2015 | Hardy Diagnostics HardyCHROM MRSA
Cat no: G307 Lot no: H15155
Expires: 2015-08-13
Container Type: 15x100mm monoplate
Packaged: 10 plates/sleeve
Storage: 2-8C on receipt. Light Sensitive.
In vitro diagnostic
www.Har Terminated |
JSO | K102922 |
| Jul 29, 2015 | Hardy Diagnostics Hardy Diagnostics
VRE Broth, 5ml
container type: 16x100mm tube
packaged: 20 tubes/box
fill: 5ml
Product Usage:
BEA (Bile Esculin Azide) Broth with Vancomycin is for the surveillance of vancomycin re Terminated |
JSO | None listed |
| Jul 29, 2015 | Hardy Diagnostics Hardy Diagnostics
BEA Broth with Vancomycin
container type: 13x100mm tube
packaged: 20 tubes/box
fill: 2ml
Product Usage:
BEA (Bile Esculin Azide) Broth with Vancomycin is for the surveillance of va Terminated |
JSO | None listed |
| Jul 29, 2015 | Hardy Diagnostics Hardy Diagnostics
BEA Agar with VGA
container type: 15x100mm monoplate
packaged: 10 places/sleeve
Product Usage:
BEA (Bile Esculin Azide) Agar with Vacomycin, Gentamicin, and Amphotericin B is for t Terminated |
JSO | None listed |
| Jul 29, 2015 | Hardy Diagnostics Hardy Diagnostics
BEA Agar with Vancomycin
container type: 15x100mm monoplate
packaged: 10 plates/sleeve
Product Usage:
BEA (Bile Esculin Agar) with Azide and Vancomycin for VRE is used as a direct Terminated |
JSO | None listed |
| Jul 29, 2015 | Hardy Diagnostics Hardy Diagnostics
MDR Acinetobacter
container type: 15x100mm monoplate
packaged: 10 plates/sleeve
Product Usage:
MDR Acinetobacter is for the primary selective screening for detection and differenti Terminated |
JSO | None listed |
| Jul 29, 2015 | Hardy Diagnostics Hardy Diagnostics
BHI with CIPRO, 1ug/ml
container type: 16x100mm tube
packaged: 20 tubes/box
Product Usage:
Brain Heart Infusion Broth with Ciprofloxacin, 1ug is for use as pre-enrichment broth for Terminated |
JSO | None listed |
| Jul 29, 2015 | Hardy Diagnostics Hardy Diagnostics
MacConkey Agar with CiPRP, 1ug/ml
Container type: 15x100mm monoplate
packaged: 10 plates/sleeve
Product Usage:
MacConkey Agar with Ciprofloxacin is used as a screening medium for t Terminated |
JSO | None listed |
| Jul 22, 2015 | Hardy Diagnostics HardyCHROM VRE Agar-RSR
Cat no: GA333 Lot no: H15055
Expires: 2015-07-04
Container type: 15x100mm monoplate
Packaged: 10 plates/sleeve
Storage 2 to 8 degrees C on receipt
Chromogenic medium for stoo Terminated |
JSO | None listed |
| Apr 14, 2015 | Hardy Diagnostics Hardy Diagnostics cat no. G327 HardyCHROM SS Agar
(HardyCHROM Salmonella Shigella)
Cat no: G327
Container type: 15x100mm monoplate
Packaged: 10 plates/sleeve
Storage: 2 to 8 degrees C. on receipt i Terminated |
JSI | None listed |