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FDA 510(k)

DBEST COCAINE TEST KIT

K-Number: K983191 · 1998-11-18

ApplicantAmeritek, Inc.
Decision Date1998-11-18
Product CodeDIO
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DBEST COCAINE TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Ameritek, Inc.. It received FDA 510(k) clearance on 1998-11-18 under 510(k) number K983191. 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 DBEST COCAINE TEST KIT?

DBEST COCAINE TEST KIT is a medical device that received FDA 510(k) clearance on 1998-11-18. The listed applicant is Ameritek, Inc.. The 510(k) number is K983191.

When did DBEST COCAINE TEST KIT receive FDA 510(k) clearance?

DBEST COCAINE TEST KIT received FDA 510(k) clearance on 1998-11-18, under 510(k) number K983191.

Who is the listed applicant for DBEST COCAINE TEST KIT?

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

What is the FDA product code for DBEST COCAINE TEST KIT?

The FDA product code for DBEST COCAINE TEST KIT is DIO.

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Other records listing Ameritek, 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.

K001215DBEST HCG 2 IU/ML TEST KITK990873DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USEK990681DBSET MULTIDRUG SCREEN TEST KITK984269DBEST OCCULT BLOOD TEST KITK983188DBEST TETRAHYDROCANNABINOL TEST KITK983190DBEST OPIATES TEST KIT

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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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