EMIT ETS PLUS ETHYL ALCOHOL ASSAY
FDA 510(k) clearance K903228 · decided 1990-08-17
Clearance details
- K-number
- K903228
- Device name
- EMIT ETS PLUS ETHYL ALCOHOL ASSAY
- Applicant
- Syva Co.
- Decision
- Substantially Equivalent
- Date received
- 1990-07-23
- Decision date
- 1990-08-17
- Days to decision
- 25 days
- Clearance type
- Traditional
- Product code
- DMI
- Device class
- 2
- Regulation number
- 862.3040
- 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.