VISUALINE II (ALSO KNOWN AS SUNLINE) BARITURATES— 510(k) K014089
Substantially EquivalentSun Biomedical Laboratories, Inc.
FDA 510(k) clearance K014089 for VISUALINE II (ALSO KNOWN AS SUNLINE) BARITURATES, Substantially Equivalent on 2002-04-25. Applicant: Sun Biomedical Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Sun Biomedical Laboratories, Inc.
- Product code
- Code DIS
- Device class
- Class 2
- Regulation
- 21 CFR 862.3150
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Blackwood, NJ, US
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More clearances from Sun Biomedical Laboratories, Inc.
view all- K023856 — VISUALINE METHADONE DIPSTRIPTEST
- K023648 — VISUALINE CUP IV FOR DRUGS OF ABUSE TEST FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPHETAMI
- K020136 — VISUALINE BARBITURATES DIPSTRIP TEST
- K011499 — VISUALINE AMPHETAMINE DIPSTRIP ASSAY
- K010177 — VISUALINE II (ALSO KNOWN AS SUNLINE) AMPHETAMINE ASSAY
Data sourced from openFDA. This site is unofficial and independent of the FDA.