Cleared Traditional

INSTANT-VIEW MORPHINE (2000) URINE DIP STRIP TEST

K010079 · Alfa Scientific Designs, Inc. · Toxicology
May 2001
Decision
139d
Days
Class 2
Risk

About This 510(k) Submission

K010079 is an FDA 510(k) clearance for the INSTANT-VIEW MORPHINE (2000) URINE DIP STRIP TEST, a Radioimmunoassay, Morphine (125-i), Goat Antibody Ammonium Sulfate Sep. (Class II — Special Controls, product code DOE), submitted by Alfa Scientific Designs, Inc. (Poway, US). The FDA issued a Cleared decision on May 29, 2001, 139 days after receiving the submission on January 10, 2001. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3640.

Submission Details

510(k) Number K010079 FDA.gov
FDA Decision Cleared SESE
Date Received January 10, 2001
Decision Date May 29, 2001
Days to Decision 139 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DOE — Radioimmunoassay, Morphine (125-i), Goat Antibody Ammonium Sulfate Sep.
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3640

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