AXSYM GENTAMICIN
FDA 510(k) clearance K935376 · decided 1994-06-21
Clearance details
- K-number
- K935376
- Device name
- AXSYM GENTAMICIN
- Applicant
- Abbott Mfg., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-11-08
- Decision date
- 1994-06-21
- Days to decision
- 225 days
- Clearance type
- Traditional
- Product code
- LCD
- Device class
- 2
- Regulation number
- 862.3450
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Abbott Park, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Abbott AxSYM Gentamicin Reagent - Is a reagent for in vitro diagnostic use. This reagent s recall (Z-0930-2008) | Abbott Diagnostic International, Ltd. | 2008-02-26 |