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FDA 510(k)

MODIFICATION TO:FASTIX THC/COC DRUG SCREEN DIPSTICK TEST, FASTIX THC/COC/MET DRUG SCREEN DIPSTICK TEST, FASTIX OPI/MET

K-Number: K012541 · 2001-09-04

ApplicantBranan Medical Corp.
Decision Date2001-09-04
Product CodeLDJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO:FASTIX THC/COC DRUG SCREEN DIPSTICK TEST, FASTIX THC/COC/MET DRUG SCREEN DIPSTICK TEST, FASTIX OPI/MET is the device name listed in this FDA 510(k) record. The listed applicant is Branan Medical Corp.. It received FDA 510(k) clearance on 2001-09-04 under 510(k) number K012541. The device is classified under product code LDJ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO:FASTIX THC/COC DRUG SCREEN DIPSTICK TEST, FASTIX THC/COC/MET DRUG SCREEN DIPSTICK TEST, FASTIX OPI/MET?

MODIFICATION TO:FASTIX THC/COC DRUG SCREEN DIPSTICK TEST, FASTIX THC/COC/MET DRUG SCREEN DIPSTICK TEST, FASTIX OPI/MET is a medical device that received FDA 510(k) clearance on 2001-09-04. The listed applicant is Branan Medical Corp.. The 510(k) number is K012541.

When did MODIFICATION TO:FASTIX THC/COC DRUG SCREEN DIPSTICK TEST, FASTIX THC/COC/MET DRUG SCREEN DIPSTICK TEST, FASTIX OPI/MET receive FDA 510(k) clearance?

MODIFICATION TO:FASTIX THC/COC DRUG SCREEN DIPSTICK TEST, FASTIX THC/COC/MET DRUG SCREEN DIPSTICK TEST, FASTIX OPI/MET received FDA 510(k) clearance on 2001-09-04, under 510(k) number K012541.

Who is the listed applicant for MODIFICATION TO:FASTIX THC/COC DRUG SCREEN DIPSTICK TEST, FASTIX THC/COC/MET DRUG SCREEN DIPSTICK TEST, FASTIX OPI/MET?

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

What is the FDA product code for MODIFICATION TO:FASTIX THC/COC DRUG SCREEN DIPSTICK TEST, FASTIX THC/COC/MET DRUG SCREEN DIPSTICK TEST, FASTIX OPI/MET?

The FDA product code for MODIFICATION TO:FASTIX THC/COC DRUG SCREEN DIPSTICK TEST, FASTIX THC/COC/MET DRUG SCREEN DIPSTICK TEST, FASTIX OPI/MET is LDJ.

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Other records listing Branan Medical Corp. as applicant

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.

K122633TOXCUP DRUG SCREEN CUPK122752FASTECT II PPX DRUG SCREEN DIPSTICK, FASTECT II DRUG SCREEN DIPSTICK, QUICKTOX DRUG SCREEN DIPCARDK040203MONITECT MDMA DRUG SCREEN CASSETTE TEST, MODEL MC22; FASTECT II MDMA DRUG SCREEN DIPSTICK TEST, MODEL MF22K032057TOXCUP DRUG SCREEN CUP AMP/COC/MET/OPI/PCP/THCK030113MONITECT OXYCODONE DRUG SCREEN CASSETTE TEST, MODEL MC 23, FASTECT OXYCODONE DRUG SCREEN DIPSTICK TEST, MODEL MD23K023489QUICKTOX MULTIPLE DRUG DIPCARD

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Related Devices (Code: LDJ)

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.

K232732Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50Co-Innovation Biotech Co., Ltd.K232604LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit (Cassette)Hangzhou Laihe Biotech Co., Ltd.K223162Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COTHealgen Scientific,, LLCK192515BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20Shenzhen Bioeasy Biotechnology Co., Ltd.K153741CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana TestHangzhou Clongene Biotech Co., Ltd.K130213QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICELumiquick Diagnostics, Inc.

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.

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