QMS VANCOMYCIN
FDA 510(k) clearance K050419 · decided 2005-04-01
Clearance details
- K-number
- K050419
- Device name
- QMS VANCOMYCIN
- Applicant
- Seradyn, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-02-18
- Decision date
- 2005-04-01
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- LEH
- Device class
- 2
- Regulation number
- 862.3950
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Seradyn QMS Vancomycin reagents, Part Number: 0373589. Seradyn, Inc, Indianapolis, IN. recall (Z-1102-2008) | Seradyn, Inc. | 2008-04-29 |