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FDA 510(k)

ABUSCREEN(R) ONLINE(TM) FOR THC(50/100)(100TEST KT

K-Number: K913414 · 1991-09-25

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1991-09-25
Product CodeLAT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ABUSCREEN(R) ONLINE(TM) FOR THC(50/100)(100TEST KT is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1991-09-25 under 510(k) number K913414. The device is classified under product code LAT. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABUSCREEN(R) ONLINE(TM) FOR THC(50/100)(100TEST KT?

ABUSCREEN(R) ONLINE(TM) FOR THC(50/100)(100TEST KT is a medical device that received FDA 510(k) clearance on 1991-09-25. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K913414.

When did ABUSCREEN(R) ONLINE(TM) FOR THC(50/100)(100TEST KT receive FDA 510(k) clearance?

ABUSCREEN(R) ONLINE(TM) FOR THC(50/100)(100TEST KT received FDA 510(k) clearance on 1991-09-25, under 510(k) number K913414.

Who is the listed applicant for ABUSCREEN(R) ONLINE(TM) FOR THC(50/100)(100TEST KT?

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

What is the FDA product code for ABUSCREEN(R) ONLINE(TM) FOR THC(50/100)(100TEST KT?

The FDA product code for ABUSCREEN(R) ONLINE(TM) FOR THC(50/100)(100TEST KT is LAT.

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Other records listing Roche Diagnostic Systems, 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.

K983698MODIFICATION TO ABUSCREEN ONLINE BARBITURATESK983702MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINESK983704MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINEK983556ABUSCREEN ONLINE BENZ 300 CALIBRATORSK983555ABUSCREEN ONLINE BENZ 200 CALIBRATORSK983700MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE

View all 296 devices →

Related Devices (Code: LAT)

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.

K011426PSYCHEMEDICS RIA CANNABINOID ASSAYPsychemedics Corp.K961620ABISCREEN ONLINE FOR CANNABINOIDS - ES 50/100Roche Diagnostic Systems, Inc.K936135SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF MARIJUANA IN PERSPIRATIONSudormed, Inc.K914507DOUBLE ANTIBODY CANNABIONOIDS/QUAIL DETER IN URINEDiagnostic Products Corp.K913865URINE THC DIRECT RIA KIT (I-125)Immunalysis CorporationK912574ABUSCREEN ONLINE FOR THC (50 AND 100)Roche Diagnostic Systems, 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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