VALPROIC ACID ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM— 510(k) K964442
Substantially EquivalentBayer Corp.
FDA 510(k) clearance K964442 for VALPROIC ACID ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM, Substantially Equivalent on 1996-12-18. Applicant: Bayer Corp.. Device class: 2.
Clearance details
- Applicant
- Bayer Corp.
- 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
- Tarrytown, NY, 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 Bayer Corp.
view all- K024062 — ASCENSIA BREEZE BLOOD GLUCOSE METER
- K023944 — BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST
- K024017 — BAYER ADVIA CENTAUR HER-2/NEU ASSAY
- K024234 — ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONAL
- K022288 — COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.