ABUSCREEN ONTRAK POS. REF. CONTROL FOR AMPHETAMINE— 510(k) K893857
Substantially EquivalentRoche Diagnostic Systems, Inc.
FDA 510(k) clearance K893857 for ABUSCREEN ONTRAK POS. REF. CONTROL FOR AMPHETAMINE, Substantially Equivalent on 1989-08-03. Applicant: Roche Diagnostic Systems, Inc.. Device class: 1.
Clearance details
- Applicant
- Roche Diagnostic Systems, Inc.
- Product code
- Code LAS
- Device class
- Class 1
- Regulation
- 21 CFR 862.3280
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Montclair, NJ, US
Recent devices under product code LAS
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