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FDA 510(k)

ONE STEP DRUG TEST - AMP/MET/MOR/THC/COC

K-Number: K060810 · 2006-08-07

ApplicantInd Diagnostic, Inc.
Decision Date2006-08-07
Product CodeDKZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ONE STEP DRUG TEST - AMP/MET/MOR/THC/COC is the device name listed in this FDA 510(k) record. The listed applicant is Ind Diagnostic, Inc.. It received FDA 510(k) clearance on 2006-08-07 under 510(k) number K060810. 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 ONE STEP DRUG TEST - AMP/MET/MOR/THC/COC?

ONE STEP DRUG TEST - AMP/MET/MOR/THC/COC is a medical device that received FDA 510(k) clearance on 2006-08-07. The listed applicant is Ind Diagnostic, Inc.. The 510(k) number is K060810.

When did ONE STEP DRUG TEST - AMP/MET/MOR/THC/COC receive FDA 510(k) clearance?

ONE STEP DRUG TEST - AMP/MET/MOR/THC/COC received FDA 510(k) clearance on 2006-08-07, under 510(k) number K060810.

Who is the listed applicant for ONE STEP DRUG TEST - AMP/MET/MOR/THC/COC?

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

What is the FDA product code for ONE STEP DRUG TEST - AMP/MET/MOR/THC/COC?

The FDA product code for ONE STEP DRUG TEST - AMP/MET/MOR/THC/COC is DKZ.

Other records listing Ind Diagnostic, 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.

K103037IND URINARY TRACT INFECTION (UTI) TEST STRIPSK100031IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10K063390URINE CHEMISTRY ANALYZER UR-50K052694ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES.K052662ONE STEP FSH MENOPAUSAL TESTK050741IND ONE STEP HCG PREGNANCY TEST - CASSETTE FORMAT

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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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