GENTAMICIN 120 UG, STREPTOMYCIN 30 UG SENSI-DISC SUSPECTIBILITY TESTS
FDA 510(k) clearance K943407 · decided 1994-10-27
Clearance details
- K-number
- K943407
- Device name
- GENTAMICIN 120 UG, STREPTOMYCIN 30 UG SENSI-DISC SUSPECTIBILITY TESTS
- Applicant
- Becton Dickinson Microbiology Systems
- Decision
- Substantially Equivalent
- Date received
- 1994-07-14
- Decision date
- 1994-10-27
- Days to decision
- 105 days
- Clearance type
- Traditional
- Product code
- JTN
- Device class
- 2
- Regulation number
- 866.1620
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Cockeysville, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.