TXIT D.A.U. BARBITURATE ASSAY (MODIFICATION)— 510(k) K920314
Substantially EquivalentSyntex Corp.
FDA 510(k) clearance K920314 for TXIT D.A.U. BARBITURATE ASSAY (MODIFICATION), Substantially Equivalent on 1992-04-17. Applicant: Syntex Corp.. Device class: 2.
Clearance details
- Applicant
- Syntex Corp.
- Product code
- Code DIS
- Device class
- Class 2
- Regulation
- 21 CFR 862.3150
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Jose, CA, US
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