EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109UL— 510(k) K011878
Substantially EquivalentSyva Co.
FDA 510(k) clearance K011878 for EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109UL, Substantially Equivalent on 2001-08-13. Applicant: Syva Co.. Device class: 2.
Clearance details
- Applicant
- Syva Co.
- Product code
- Code DKJ
- Device class
- Class 2
- Regulation
- 21 CFR 862.3830
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cupertino, CA, US
Recent devices under product code DKJ
view allMore clearances from Syva Co.
view all- K012257 — EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229
- K011947 — EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL
- K011528 — EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229
- K011347 — EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229
- K993980 — SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL
Data sourced from openFDA. This site is unofficial and independent of the FDA.