Submission Details
| 510(k) Number | K100051 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 08, 2010 |
| Decision Date | July 06, 2010 |
| Days to Decision | 179 days |
| Submission Type | Abbreviated |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
Cleared
Abbreviated
INSTANT-VIEW MILTI-DRUG OF ABUSE URINE TEST (PANEL, CUP), INSTANT-VERDICT MULTI-DRUG OF ABUSE URINE TEST (PANEL, CUP)
Jul 2010
Decision
179d
Days
Class 2
Risk
About This 510(k) Submission
K100051 is an FDA 510(k) clearance for the INSTANT-VIEW MILTI-DRUG OF ABUSE URINE TEST (PANEL, CUP), INSTANT-VERDICT MULTI-DRUG OF ABUSE URINE TEST (PANEL, CUP), a Enzyme Immunoassay, Opiates (Class II — Special Controls, product code DJG), submitted by Alfa Scientific Designs, Inc. (Poway, US). The FDA issued a Cleared decision on July 6, 2010, 179 days after receiving the submission on January 8, 2010. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.
Device Classification
| Product Code | DJG — Enzyme Immunoassay, Opiates |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.3650 |
Manufacturer
Similar Devices — DJG Enzyme Immunoassay, Opiates
All 214
K252684 · Medtox Diagnostics, Inc.
· Jan 2026
K250741 · Randox Laboratories Limited
· Jan 2026
K253082 · Lin-Zhi International, Inc.
· Jan 2026
K252520 · Immunalysis Corporation
· Sep 2025
K251972 · Healgen Scientific, LLC
· Aug 2025
K251634 · Lin-Zhi International, Inc.
· Jun 2025
More from Alfa Scientific Designs, Inc.
View all
K173303
· DKZ · Feb 2018
K173212
· KHE · Feb 2018
K152122
· DKZ · Jun 2016
K131645
· DKZ · Oct 2013
K070660
· KHE · Jun 2007