VISUALINE II CANNABINOIDS (THC)— 510(k) K950445
Substantially EquivalentSun Biomedical Laboratories, Inc.
FDA 510(k) clearance K950445 for VISUALINE II CANNABINOIDS (THC), Substantially Equivalent on 1995-05-02. Applicant: Sun Biomedical Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Sun Biomedical Laboratories, 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
- Cherry Hill, NJ, US
Recent devices under product code LDJ
view all- K232732 — Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50
- K232604 — LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit (Cassette)
- K223162 — Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT
- K192515 — BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20
- K153741 — CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test
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
- K014089 — VISUALINE II (ALSO KNOWN AS SUNLINE) BARITURATES
- K020136 — VISUALINE BARBITURATES DIPSTRIP TEST
- K011499 — VISUALINE AMPHETAMINE DIPSTRIP ASSAY
Data sourced from openFDA. This site is unofficial and independent of the FDA.