FDA 510(k)

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

K-Number: K002418 · 2000-11-22

Decision Date2000-11-22

Product CodeDOE

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

BRANAN MEDICAL CORPORATION MONITECT MORPHINE 300 DRUG SCREEN TEST, MODEL 133C AND 133D is the device name listed in this FDA 510(k) record. The listed applicant is Branan Medical Corporation. It received FDA 510(k) clearance on 2000-11-22 under 510(k) number K002418. The device is classified under product code DOE. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BRANAN MEDICAL CORPORATION MONITECT MORPHINE 300 DRUG SCREEN TEST, MODEL 133C AND 133D?

BRANAN MEDICAL CORPORATION MONITECT MORPHINE 300 DRUG SCREEN TEST, MODEL 133C AND 133D is a medical device that received FDA 510(k) clearance on 2000-11-22. The listed applicant is Branan Medical Corporation. The 510(k) number is K002418.

When did BRANAN MEDICAL CORPORATION MONITECT MORPHINE 300 DRUG SCREEN TEST, MODEL 133C AND 133D receive FDA 510(k) clearance?

BRANAN MEDICAL CORPORATION MONITECT MORPHINE 300 DRUG SCREEN TEST, MODEL 133C AND 133D received FDA 510(k) clearance on 2000-11-22, under 510(k) number K002418.

Who is the listed applicant for BRANAN MEDICAL CORPORATION MONITECT MORPHINE 300 DRUG SCREEN TEST, MODEL 133C AND 133D?

The FDA 510(k) record lists Branan Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BRANAN MEDICAL CORPORATION MONITECT MORPHINE 300 DRUG SCREEN TEST, MODEL 133C AND 133D?

The FDA product code for BRANAN MEDICAL CORPORATION MONITECT MORPHINE 300 DRUG SCREEN TEST, MODEL 133C AND 133D is DOE.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Branan Medical Corporation as applicant

K103227ORATECT ORAL FLUID DRUG SCREEN DEVICES K082508FASTECT II BUP DRUG SCREEN DIPSTICK AND QUICKTOX BUP DRUG SCREEN DIPCARD K002265BRANAN MEDICAL CORPORATION MONITECT METHAMPHETAMINE DRUG SCREEN TEST K002264BRANAN MEDICAL CORPORATION MONITECT COCAINE DRUG SCREEN TEST K002268BRANAN MEDICAL CORPORATION MONITECT MORPHINE 2000 DRUG SCREEN TEST K002342BRANAN MEDICAL CORPORATION MONITECT BZO DRUG SCREEN TEST

View all 11 devices →

Related Devices (Code: DOE)

K010080INSTANT-VIEW MORPHINE (2000) URINE CASSETTE TESTAlfa Scientific Designs, Inc.K010079INSTANT-VIEW MORPHINE (2000) URINE DIP STRIP TESTAlfa Scientific Designs, Inc.K011011LIVESURE MORPHINE SCREEN TESTPan Probe Biotech, Inc.K951319ROCHE ABUSCREEN ONLINE FOR OPIATES 1000 TEST KIT-2000 NG/ML CUTOFF OLYMPUS AU800 INSTRUMENT APPLICATIONRoche Diagnostic Systems, Inc.K935055ROCHE ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE (HIGH CUT-OFF)Roche Diagnostic Systems, Inc.K933572URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125)Immunalysis Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.