HARDYCHROM MRSA— 510(k) K102922
Substantially EquivalentHardy Diagnostics
FDA 510(k) clearance K102922 for HARDYCHROM MRSA, Substantially Equivalent on 2011-05-04. Applicant: Hardy Diagnostics. Device class: 2.
Clearance details
- Applicant
- Hardy Diagnostics
- Product code
- Code JSO
- Device class
- Class 2
- Regulation
- 21 CFR 866.1700
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Maria, CA, US
Recent devices under product code JSO
view allMore clearances from Hardy Diagnostics
view allAdverse events under product code JSO
product code JSO- Malfunction
- 602
- Total
- 602
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K102922
K-number listed on FDA's recall record- Z-2298-2020 — 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). Not intended to diagnose infection of guide therapy. Further testing required for susceptibility or typing. Container Type: 15 x 100mm monoplate Packaged: 10 plates/sleeve STORAGE: 2-8 degree C on receipt, LIGHT SENSITIVE IVD UDI: (01)08165760201400 (10)447694 (17)191206
- Z-2463-2015 — 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.HardyDiagnostics.com
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K102922.
Data sourced from openFDA. This site is unofficial and independent of the FDA.