CEDIA(TM) PHENOBARBITAL ASSAY— 510(k) K904413
Substantially EquivalentMicrogenics Corp.
FDA 510(k) clearance K904413 for CEDIA(TM) PHENOBARBITAL ASSAY, Substantially Equivalent on 1990-11-05. Applicant: Microgenics Corp.. Device class: 2.
Clearance details
- Applicant
- Microgenics Corp.
- Product code
- Code LAF
- Device class
- Class 2
- Regulation
- 21 CFR 862.3610
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Concord, CA, US
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