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FDA 510(k)

TOXI-LAB CANNABINOID THC SCREEN

K-Number: K831456 · 1983-06-30

ApplicantMarion Laboratories, Inc.
Decision Date1983-06-30
Product CodeDKE
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

TOXI-LAB CANNABINOID THC SCREEN is the device name listed in this FDA 510(k) record. The listed applicant is Marion Laboratories, Inc.. It received FDA 510(k) clearance on 1983-06-30 under 510(k) number K831456. 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 TOXI-LAB CANNABINOID THC SCREEN?

TOXI-LAB CANNABINOID THC SCREEN is a medical device that received FDA 510(k) clearance on 1983-06-30. The listed applicant is Marion Laboratories, Inc.. The 510(k) number is K831456.

When did TOXI-LAB CANNABINOID THC SCREEN receive FDA 510(k) clearance?

TOXI-LAB CANNABINOID THC SCREEN received FDA 510(k) clearance on 1983-06-30, under 510(k) number K831456.

Who is the listed applicant for TOXI-LAB CANNABINOID THC SCREEN?

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

What is the FDA product code for TOXI-LAB CANNABINOID THC SCREEN?

The FDA product code for TOXI-LAB CANNABINOID THC SCREEN is DKE.

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Other records listing Marion Laboratories, 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.

K883391POLYMER ADHESIVE BANDAGEK875182MODIFIED LABELING FOR TOXI-LAB THC SCREENK875181MODIFIED LABELING FOR TOXI-LAB BROAD SPECTRUMK874554ENVICLUSIVE (TM)K874552ENVISAN PADK874551ENVINET(TM)

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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

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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