VISUALINE II (ALSO KNOWN AS SUNLINE) AMPHETAMINE ASSAY— 510(k) K010177
Substantially EquivalentSun Biomedical Laboratories, Inc.
FDA 510(k) clearance K010177 for VISUALINE II (ALSO KNOWN AS SUNLINE) AMPHETAMINE ASSAY, Substantially Equivalent on 2001-05-17. Applicant: Sun Biomedical Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Sun Biomedical Laboratories, Inc.
- Product code
- Code DKZ
- Device class
- Class 2
- Regulation
- 21 CFR 862.3100
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Blackwood, NJ, US
Recent devices under product code DKZ
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Data sourced from openFDA. This site is unofficial and independent of the FDA.