ACS GENTAMICIN
FDA 510(k) clearance K953020 · decided 1995-08-02
Clearance details
- K-number
- K953020
- Device name
- ACS GENTAMICIN
- Applicant
- Ciba Corning Diagnostics Corp.
- Decision
- Substantially Equivalent
- Date received
- 1995-06-29
- Decision date
- 1995-08-02
- Days to decision
- 34 days
- Clearance type
- Traditional
- Product code
- LCD
- Device class
- 2
- Regulation number
- 862.3450
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- East Walpole, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.