VENTREZYME PHENYTOIN KIT IMMUNOASSAY— 510(k) K842161
Substantially EquivalentVentrex Laboratories, Inc.
FDA 510(k) clearance K842161 for VENTREZYME PHENYTOIN KIT IMMUNOASSAY, Substantially Equivalent on 1984-07-09. Applicant: Ventrex Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Ventrex Laboratories, Inc.
- 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
- Mchenry, IL, US
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