EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229— 510(k) K012257
Substantially EquivalentSyva Co.
FDA 510(k) clearance K012257 for EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229, Substantially Equivalent on 2001-08-03. Applicant: Syva Co.. Device class: 2.
Clearance details
- Applicant
- Syva Co.
- Product code
- Code DKZ
- Device class
- Class 2
- Regulation
- 21 CFR 862.3100
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Cupertino, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.