EMIT ETS PLUS ETHYL ALCOHOL ASSAY— 510(k) K903228
Substantially EquivalentSyva Co.
FDA 510(k) clearance K903228 for EMIT ETS PLUS ETHYL ALCOHOL ASSAY, Substantially Equivalent on 1990-08-17. Applicant: Syva Co.. Device class: 2.
Clearance details
- Applicant
- Syva Co.
- Product code
- Code DMI
- Device class
- Class 2
- Regulation
- 21 CFR 862.3040
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Palo Alto, CA, US
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- K011528 — EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229
- K011347 — EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229
Data sourced from openFDA. This site is unofficial and independent of the FDA.