INNOFLUOR VANCOMYCIN CALIBRATOR SET
FDA 510(k) clearance K872644 · decided 1987-07-21
Clearance details
- K-number
- K872644
- Device name
- INNOFLUOR VANCOMYCIN CALIBRATOR SET
- Applicant
- Innotron of Oregon, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-07-06
- Decision date
- 1987-07-21
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- DLJ
- Device class
- 2
- Regulation number
- 862.3200
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Portland, OR, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Multigent Vancomycin Calibrators; Manufactured by Microgenics Corp, Fremont, CA. Distribut recall (Z-0297-2012) | Microgenics Corp | 2011-11-28 |