EMIT-ST SERUM PHENOBARBITAL CALIBRATOR— 510(k) K811622
Substantially EquivalentSyva Co.
FDA 510(k) clearance K811622 for EMIT-ST SERUM PHENOBARBITAL CALIBRATOR, Substantially Equivalent on 1981-06-25. Applicant: Syva Co.. Device class: 2.
Clearance details
- Applicant
- Syva Co.
- Product code
- Code DLJ
- Device class
- Class 2
- Regulation
- 21 CFR 862.3200
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.