BHI W/VANCOMYCIN AGAR— 510(k) K964560
Substantially EquivalentHardy Diagnostics
FDA 510(k) clearance K964560 for BHI W/VANCOMYCIN AGAR, Substantially Equivalent on 1997-01-15. 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 K964560
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K964560.
Data sourced from openFDA. This site is unofficial and independent of the FDA.