ABBOT AEROSET PHENYTOIN ASSAY & ABBOT AEROSET PHENYTOIN CALIBRATORS— 510(k) K993026
Substantially EquivalentSyva Co.
FDA 510(k) clearance K993026 for ABBOT AEROSET PHENYTOIN ASSAY & ABBOT AEROSET PHENYTOIN CALIBRATORS, Substantially Equivalent on 2000-01-27. Applicant: Syva Co.. Device class: 2.
Clearance details
- Applicant
- Syva Co.
- Product code
- Code DIP
- Device class
- Class 2
- Regulation
- 21 CFR 862.3350
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Jose, CA, US
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More clearances from Syva Co.
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- K011947 — EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL
- K011528 — EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229
- K993980 — SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL
Data sourced from openFDA. This site is unofficial and independent of the FDA.