EMIT(R) 2000 GENTAMICIN ASSAY/CALIBRATORS
FDA 510(k) clearance K913410 · decided 1991-09-16
Clearance details
- K-number
- K913410
- Device name
- EMIT(R) 2000 GENTAMICIN ASSAY/CALIBRATORS
- Applicant
- Syva Co.
- Decision
- Substantially Equivalent
- Date received
- 1991-07-31
- Decision date
- 1991-09-16
- Days to decision
- 47 days
- Clearance type
- Traditional
- Product code
- DMB
- Device class
- 2
- Regulation number
- 862.3620
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Palo Alto, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.