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FDA 510(k)

TOXI-LAB RAPID SCREEN

K-Number: K823523 · 1983-01-14

ApplicantMarion Laboratories, Inc.
Decision Date1983-01-14
Product CodeDKJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

TOXI-LAB RAPID 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 1983-01-14 under 510(k) number K823523. The device is classified under product code DKJ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOXI-LAB RAPID SCREEN?

TOXI-LAB RAPID SCREEN is a medical device that received FDA 510(k) clearance on 1983-01-14. The listed applicant is Marion Laboratories, Inc.. The 510(k) number is K823523.

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

TOXI-LAB RAPID SCREEN received FDA 510(k) clearance on 1983-01-14, under 510(k) number K823523.

Who is the listed applicant for TOXI-LAB RAPID 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 RAPID SCREEN?

The FDA product code for TOXI-LAB RAPID SCREEN is DKJ.

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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: DKJ)

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.

K093939ADVIA CHEMISTRY SALICYLATE REAGENTSiemens Healthcare DiagnosticsK042329SALICYLATE-SL ASSAYDiagnostic Chemicals , Ltd.K020794SALICYLATE ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEMBayer Diagnostics Corp.K014173SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATORBeckman Coulter, Inc.K011878EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109ULSyva Co.K981872SALICYLATE-SL ASSAY CATALOGUE NUMBER 511-20,511-40Diagnostic Chemicals , Ltd.

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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