ABUSCREEN ONLINE FOR CANNABINOIDS (1000 TEST KIT)— 510(k) K981585
Substantially EquivalentRoche Diagnostic Systems, Inc.
FDA 510(k) clearance K981585 for ABUSCREEN ONLINE FOR CANNABINOIDS (1000 TEST KIT), Substantially Equivalent on 1998-05-28. Applicant: Roche Diagnostic Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostic Systems, Inc.
- Product code
- Code LDJ
- Device class
- Class 2
- Regulation
- 21 CFR 862.3870
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Somerville, NJ, US
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view allData sourced from openFDA. This site is unofficial and independent of the FDA.