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FDA 510(k)

DRUGALYZER DTK-1000 KIT PRESUMPTIVE DRUG

K-Number: K792282 · 1980-02-29

ApplicantCalifornia Medical Developments, Inc.
Decision Date1980-02-29
Product CodeDKE
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DRUGALYZER DTK-1000 KIT PRESUMPTIVE DRUG is the device name listed in this FDA 510(k) record. The listed applicant is California Medical Developments, Inc.. It received FDA 510(k) clearance on 1980-02-29 under 510(k) number K792282. The device is classified under product code DKE. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DRUGALYZER DTK-1000 KIT PRESUMPTIVE DRUG?

DRUGALYZER DTK-1000 KIT PRESUMPTIVE DRUG is a medical device that received FDA 510(k) clearance on 1980-02-29. The listed applicant is California Medical Developments, Inc.. The 510(k) number is K792282.

When did DRUGALYZER DTK-1000 KIT PRESUMPTIVE DRUG receive FDA 510(k) clearance?

DRUGALYZER DTK-1000 KIT PRESUMPTIVE DRUG received FDA 510(k) clearance on 1980-02-29, under 510(k) number K792282.

Who is the listed applicant for DRUGALYZER DTK-1000 KIT PRESUMPTIVE DRUG?

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

What is the FDA product code for DRUGALYZER DTK-1000 KIT PRESUMPTIVE DRUG?

The FDA product code for DRUGALYZER DTK-1000 KIT PRESUMPTIVE DRUG is DKE.

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Related Devices (Code: DKE)

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.

K003687VERDICT II THC/COC/OPI/AMP, VERDICTII THC/COC/OPI,VERDICT II THC/COC/AMP,VERDICT II THC/COC/PCP,VERDICT II THC/COCMedtox Diagnostics, Inc.K994405INSTANT-VIEW MARIJUANA URINE CASSETTE TESTAlfa Scientific Designs, Inc.K992068STATUS STIK, ACCUSIGN STIKPrinceton BioMeditech Corp.K991751STATUS CUP ACCUSIGN CUPPrinceton BioMeditech Corp.K991078ACCUSIGN DOA8, DOA8 PANEL, THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA8, THC/OPI/COC/AMP/BZO/BAR/TCA/PAP, STATUS DS DO8Princeton BioMeditech Corp.K983147ACCUSIGN DOA 8, ACCUSIGN DOA 8 PANEL, ACCUSIGN THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA 8, BIOSIGN THC/OPI/COC/AMP/PPrinceton BioMeditech Corp.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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