Cleared Traditional

BRANAN MEDICAL CORPORATION MONITECT MORPHINE 300 DRUG SCREEN TEST, MODEL 133C AND 133D

K002418 · Branan Medical Corporation · Toxicology

Nov 2000

Decision

106d

Days

Class 2

Risk

About This 510(k) Submission

K002418 is an FDA 510(k) clearance for the BRANAN MEDICAL CORPORATION MONITECT MORPHINE 300 DRUG SCREEN TEST, MODEL 133C AND 133D, a Radioimmunoassay, Morphine (125-i), Goat Antibody Ammonium Sulfate Sep. (Class II — Special Controls, product code DOE), submitted by Branan Medical Corporation (Irvine, US). The FDA issued a Cleared decision on November 22, 2000, 106 days after receiving the submission on August 8, 2000. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3640.

Submission Details

510(k) Number	K002418 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 08, 2000
Decision Date	November 22, 2000
Days to Decision	106 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Statement

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