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FDA 510(k)

AMEDITECH IMMUTEST DRUG SCREEN OPIATES

K-Number: K012483 · 2001-11-30

ApplicantAmeditech, Inc.
Decision Date2001-11-30
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AMEDITECH IMMUTEST DRUG SCREEN OPIATES is the device name listed in this FDA 510(k) record. The listed applicant is Ameditech, Inc.. It received FDA 510(k) clearance on 2001-11-30 under 510(k) number K012483. The device is classified under product code DJG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMEDITECH IMMUTEST DRUG SCREEN OPIATES?

AMEDITECH IMMUTEST DRUG SCREEN OPIATES is a medical device that received FDA 510(k) clearance on 2001-11-30. The listed applicant is Ameditech, Inc.. The 510(k) number is K012483.

When did AMEDITECH IMMUTEST DRUG SCREEN OPIATES receive FDA 510(k) clearance?

AMEDITECH IMMUTEST DRUG SCREEN OPIATES received FDA 510(k) clearance on 2001-11-30, under 510(k) number K012483.

Who is the listed applicant for AMEDITECH IMMUTEST DRUG SCREEN OPIATES?

The FDA 510(k) record lists Ameditech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMEDITECH IMMUTEST DRUG SCREEN OPIATES?

The FDA product code for AMEDITECH IMMUTEST DRUG SCREEN OPIATES is DJG.

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Other records listing Ameditech, Inc. 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.

K113501AMEDITECH CHECKCUP MULTI DRUG TEST (FLAT/ROUND CUP)K113046AMEDITECH IMMUTEST MILTI-DRUG SCREENK063015AMEDITECH IMMUTEST MULTI-DRUG SCREEN BUP/PPX/COC150K053175AMEDITECH DRUGSMARTCUPK050186AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL IIIK042975AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL II

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Related Devices (Code: DJG)

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.

K252684Labcorp Fentanyl Urine Visual TestMedtox Diagnostics, Inc.K250741Evidence MultiSTAT DOA Urine MultiPlexRandox Laboratories LimitedK253082LZI Buprenorphine II Enzyme ImmunoassayLin-Zhi International, Inc.K252520SEFRIA™ Hydrocodone Oral FluidImmunalysis CorporationK251972Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180)Healgen Scientific,, LLCK251634LZI Fentanyl III Enzyme ImmunoassayLin-Zhi International, 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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