OPUS(R) VANCOMYCIN
FDA 510(k) clearance K924957 · decided 1992-12-11
Clearance details
- K-number
- K924957
- Device name
- OPUS(R) VANCOMYCIN
- Applicant
- Pb Diagnostic Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-09-30
- Decision date
- 1992-12-11
- Days to decision
- 72 days
- Clearance type
- Traditional
- Product code
- LEH
- Device class
- 2
- Regulation number
- 862.3950
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Westwood, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.