EMIT-TOX SERUM TRICYCLIC ANTIDEPR. ASSAY— 510(k) K821743
Substantially EquivalentSyva Co.
FDA 510(k) clearance K821743 for EMIT-TOX SERUM TRICYCLIC ANTIDEPR. ASSAY, Substantially Equivalent on 1982-07-02. Applicant: Syva Co.. Device class: 2.
Clearance details
- Applicant
- Syva Co.
- Product code
- Code LFG
- Device class
- Class 2
- Regulation
- 21 CFR 862.3910
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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Recalls naming K821743
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K821743.
Data sourced from openFDA. This site is unofficial and independent of the FDA.