EMIT-AND METHOTREXATE ASSAY— 510(k) K811459
Substantially EquivalentSyva Co.
FDA 510(k) clearance K811459 for EMIT-AND METHOTREXATE ASSAY, Substantially Equivalent on 1981-06-09. Applicant: Syva Co.. Device class: Unclassified.
Clearance details
- Applicant
- Syva Co.
- Product code
- Code LAO
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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- K011947 — EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL
- K011528 — EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229
- K011347 — EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229
Recalls naming K811459
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 K811459.
Data sourced from openFDA. This site is unofficial and independent of the FDA.