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FDA 510(k)

MODIFIED LABELING FOR TOXI-LAB THC SCREEN

K-Number: K875182 · 1988-07-05

ApplicantMarion Laboratories, Inc.
Decision Date1988-07-05
Product CodeDKE
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

MODIFIED LABELING FOR TOXI-LAB 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 1988-07-05 under 510(k) number K875182. 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 MODIFIED LABELING FOR TOXI-LAB THC SCREEN?

MODIFIED LABELING FOR TOXI-LAB THC SCREEN is a medical device that received FDA 510(k) clearance on 1988-07-05. The listed applicant is Marion Laboratories, Inc.. The 510(k) number is K875182.

When did MODIFIED LABELING FOR TOXI-LAB THC SCREEN receive FDA 510(k) clearance?

MODIFIED LABELING FOR TOXI-LAB THC SCREEN received FDA 510(k) clearance on 1988-07-05, under 510(k) number K875182.

Who is the listed applicant for MODIFIED LABELING FOR TOXI-LAB 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 MODIFIED LABELING FOR TOXI-LAB THC SCREEN?

The FDA product code for MODIFIED LABELING FOR TOXI-LAB 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 BANDAGEK875181MODIFIED LABELING FOR TOXI-LAB BROAD SPECTRUMK874554ENVICLUSIVE (TM)K874552ENVISAN PADK874551ENVINET(TM)K874553ENVISAN PASTE

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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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