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FDA 510(k)

ADVANTAGE THC/COCAINE TEST

K-Number: K003708 · 2001-01-22

ApplicantAdvantage Diagnostics Corp.
Decision Date2001-01-22
Product CodeDIO
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ADVANTAGE THC/COCAINE TEST is the device name listed in this FDA 510(k) record. The listed applicant is Advantage Diagnostics Corp.. It received FDA 510(k) clearance on 2001-01-22 under 510(k) number K003708. The device is classified under product code DIO. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVANTAGE THC/COCAINE TEST?

ADVANTAGE THC/COCAINE TEST is a medical device that received FDA 510(k) clearance on 2001-01-22. The listed applicant is Advantage Diagnostics Corp.. The 510(k) number is K003708.

When did ADVANTAGE THC/COCAINE TEST receive FDA 510(k) clearance?

ADVANTAGE THC/COCAINE TEST received FDA 510(k) clearance on 2001-01-22, under 510(k) number K003708.

Who is the listed applicant for ADVANTAGE THC/COCAINE TEST?

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

What is the FDA product code for ADVANTAGE THC/COCAINE TEST?

The FDA product code for ADVANTAGE THC/COCAINE TEST is DIO.

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Other records listing Advantage Diagnostics 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.

K023712ADVANTAGE MULTIPLE DRUGS OF ABUSE TESTK013778PEACE OF MIND HOME DRUG TESTK011962ADVANTAGE MARIJUANA (THC) AND COCAINE HOME DRUG TESTK010921ADVANTAGE MARIJUANA (THC) HOME DRUG TESTK001567ADVANTAGE THC TESTK994227ADVANTAGE HCG TEST (URINE/SERUM)

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Related Devices (Code: DIO)

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.

K213211Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test SystemCarolina Liquid Chemistries Corp.K211973DRI Cocaine Metabolite AssayMicrogenics CorporationK191638Pointe Scientific Cocaine Metabolite Enzyme ImmunoassayMedtest DXK181499DRI Cocaine Metabolite AssayMicrogenics CorporationK170293Emit II Plus Cocaine Metabolite AssaySiemens Healthcare Diagnostics, Inc.K163570Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)Carolina Liquid Chemistries 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.

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