VALPROIC ACID (FPIA) KIT— 510(k) K895569
Substantially EquivalentTudor Laboratories, Inc.
FDA 510(k) clearance K895569 for VALPROIC ACID (FPIA) KIT, Substantially Equivalent on 1989-10-03. Applicant: Tudor Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Tudor Laboratories, Inc.
- Product code
- Code LEG
- Device class
- Class 2
- Regulation
- 21 CFR 862.3645
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dallas, TX, US
Recent devices under product code LEG
view all- K090358 — ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35
- K060690 — ONLINE VALPROIC ACID
- K042807 — ADVIA IMS VALPROIC ACID METHOD
- K042476 — VITROS CHEMISTRY PRODUCTS VALP REAGENT; VITRO CHEMISTRY PRODUCTS CALIBRATOR KIT 12; VITROS CHEMISTRY PRODUCTS TDM PERFOS
- K032049 — ROCHE ONLINE TDM VALPROIC ACID
More clearances from Tudor Laboratories, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.