VISUALINE AMPHETAMINE DIPSTRIP ASSAY— 510(k) K011499
Substantially EquivalentSun Biomedical Laboratories, Inc.
FDA 510(k) clearance K011499 for VISUALINE AMPHETAMINE DIPSTRIP ASSAY, Substantially Equivalent on 2001-07-17. 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
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Data sourced from openFDA. This site is unofficial and independent of the FDA.