BHI W/VANCOMYCIN AGAR
FDA 510(k) clearance K964560 · decided 1997-01-15
Clearance details
- K-number
- K964560
- Device name
- BHI W/VANCOMYCIN AGAR
- Applicant
- Hardy Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 1996-11-13
- Decision date
- 1997-01-15
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- JSO
- Device class
- 2
- Regulation number
- 866.1700
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Santa Maria, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BHI Agar with Vancomycin, for in vitro diagnostic use. Catalog # G14, Lot# 06136 recall (Z-1451-06) | Hardy Media Inc Dba Hardy Diag | 2006-08-29 |