INSTANT-VIEW MDMA (ECSTASY, XTC) URINE TEST— 510(k) K022501
Substantially EquivalentAlfa Scientific Designs, Inc.
FDA 510(k) clearance K022501 for INSTANT-VIEW MDMA (ECSTASY, XTC) URINE TEST, Substantially Equivalent on 2002-11-13. Applicant: Alfa Scientific Designs, Inc.. Device class: 2.
Clearance details
- Applicant
- Alfa Scientific Designs, Inc.
- Product code
- Code DJC
- Device class
- Class 2
- Regulation
- 21 CFR 862.3610
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Poway, CA, US
Recent devices under product code DJC
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- K181305 — OralTox Oral fluid Drug Test
- K171403 — OralTox Oral Fluid Drug Test
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)
Data sourced from openFDA. This site is unofficial and independent of the FDA.