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FDA 510(k)

DBSET MULTIDRUG SCREEN TEST KIT

K-Number: K990681 · 1999-07-15

ApplicantAmeritek, Inc.
Decision Date1999-07-15
Product CodeDKZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DBSET MULTIDRUG SCREEN 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 1999-07-15 under 510(k) number K990681. The device is classified under product code DKZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DBSET MULTIDRUG SCREEN TEST KIT?

DBSET MULTIDRUG SCREEN TEST KIT is a medical device that received FDA 510(k) clearance on 1999-07-15. The listed applicant is Ameritek, Inc.. The 510(k) number is K990681.

When did DBSET MULTIDRUG SCREEN TEST KIT receive FDA 510(k) clearance?

DBSET MULTIDRUG SCREEN TEST KIT received FDA 510(k) clearance on 1999-07-15, under 510(k) number K990681.

Who is the listed applicant for DBSET MULTIDRUG SCREEN 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 DBSET MULTIDRUG SCREEN TEST KIT?

The FDA product code for DBSET MULTIDRUG SCREEN TEST KIT is DKZ.

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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-USEK984269DBEST OCCULT BLOOD TEST KITK983188DBEST TETRAHYDROCANNABINOL TEST KITK983191DBEST COCAINE TEST KITK983190DBEST OPIATES TEST KIT

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Related Devices (Code: DKZ)

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.

K240670DRI Ecstasy Plus AssayMicrogenics CorporationK233019AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel RxHangzhou AllTest Biotech Co., Ltd.K231137Xenta Drug Screen Cup, Xenta Drug Screen DipcardXenta Biomedical Science Co., Ltd.K200363Quidel Triage® TOX Drug Screen, 94600Quidel Cardiovascular, Inc.K191099Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test PanelAtlas MedicalK182719Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterProQuidel Cardiovascular, 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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