EMIT(R) 2000 CARBAMAZEPINE ASSAY/CALIBRATORS— 510(k) K913066
Substantially EquivalentSyva Co.
FDA 510(k) clearance K913066 for EMIT(R) 2000 CARBAMAZEPINE ASSAY/CALIBRATORS, Substantially Equivalent on 1991-07-30. Applicant: Syva Co.. Device class: 2.
Clearance details
- Applicant
- Syva Co.
- Product code
- Code KLT
- Device class
- Class 2
- Regulation
- 21 CFR 862.3645
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Palo Alto, CA, US
Recent devices under product code KLT
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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
Data sourced from openFDA. This site is unofficial and independent of the FDA.