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FDA 510(k)

ABUSCREEN ONLINE TM FOR COCAINE METABOLITE

K-Number: K904995 · 1990-11-28

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1990-11-28
Product CodeKLN
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ABUSCREEN ONLINE TM FOR COCAINE METABOLITE 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 1990-11-28 under 510(k) number K904995. The device is classified under product code KLN. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABUSCREEN ONLINE TM FOR COCAINE METABOLITE?

ABUSCREEN ONLINE TM FOR COCAINE METABOLITE is a medical device that received FDA 510(k) clearance on 1990-11-28. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K904995.

When did ABUSCREEN ONLINE TM FOR COCAINE METABOLITE receive FDA 510(k) clearance?

ABUSCREEN ONLINE TM FOR COCAINE METABOLITE received FDA 510(k) clearance on 1990-11-28, under 510(k) number K904995.

Who is the listed applicant for ABUSCREEN ONLINE TM FOR COCAINE METABOLITE?

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 ONLINE TM FOR COCAINE METABOLITE?

The FDA product code for ABUSCREEN ONLINE TM FOR COCAINE METABOLITE is KLN.

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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

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Related Devices (Code: KLN)

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.

K010868PSYCHEMEDICS RIA COCAINE ASSAYPsychemedics Corp.K913867URINE COCAINE METABOLITE DIRECT RIA KIT (I-125)Immunalysis CorporationK913722ABUSCREEN(R) RADIOIMMUN FOR COCAINE METABOLITERoche Diagnostic Systems, Inc.K912756ABUSCREEN RADIOIMMUNOASSAY FOR COCAINE METABOLITERoche Diagnostic Systems, Inc.K910123TARGET COCAINE METABOLITE-VV-Tech, Inc.K910122TARGET COCAINE METABOLITE-RV-Tech, 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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