MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAY— 510(k) K983268
Substantially EquivalentDiagnostic Reagents, Inc.
FDA 510(k) clearance K983268 for MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAY, Substantially Equivalent on 1998-11-18. Applicant: Diagnostic Reagents, Inc.. Device class: 2.
Clearance details
- Applicant
- Diagnostic Reagents, Inc.
- Product code
- Code LFH
- Device class
- Class 2
- Regulation
- 21 CFR 862.3910
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
Recent devices under product code LFH
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