INSTANT-VIEW MARIJUANA URINE CASSETTE TEST— 510(k) K994405
Substantially EquivalentAlfa Scientific Designs, Inc.
FDA 510(k) clearance K994405 for INSTANT-VIEW MARIJUANA URINE CASSETTE TEST, Substantially Equivalent on 2000-06-02. Applicant: Alfa Scientific Designs, Inc.. Device class: 2.
Clearance details
- Applicant
- Alfa Scientific Designs, Inc.
- Product code
- Code DKE
- Device class
- Class 2
- Regulation
- 21 CFR 862.3870
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Recent devices under product code DKE
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- K992068 — STATUS STIK, ACCUSIGN STIK
- K991751 — STATUS CUP ACCUSIGN CUP
- K991078 — ACCUSIGN DOA8, DOA8 PANEL, THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA8, THC/OPI/COC/AMP/BZO/BAR/TCA/PAP, STATUS DS DO8
- K983147 — ACCUSIGN DOA 8, ACCUSIGN DOA 8 PANEL, ACCUSIGN THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA 8, BIOSIGN THC/OPI/COC/AMP/P
More clearances from Alfa Scientific Designs, Inc.
view all- K173303 — INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use)
- K173212 — Instant-view-PLUS immunochemical Fecal Occult Blood Test
- K152122 — Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use)
- K131645 — INSTANT-VIEW MULTI-DRUG OF ABUSE URINE TEST (CUP, PANEL CASSETTE)
- K100051 — INSTANT-VIEW MILTI-DRUG OF ABUSE URINE TEST (PANEL, CUP), INSTANT-VERDICT MULTI-DRUG OF ABUSE URINE TEST (PANEL, CUP)
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