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FDA 510(k)

ABUSCREEN(R) ONTRAK(TM) FOR COCAINE

K-Number: K881815 · 1988-07-29

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1988-07-29
Product CodeDIO
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ABUSCREEN(R) ONTRAK(TM) FOR COCAINE 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 1988-07-29 under 510(k) number K881815. The device is classified under product code DIO. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABUSCREEN(R) ONTRAK(TM) FOR COCAINE?

ABUSCREEN(R) ONTRAK(TM) FOR COCAINE is a medical device that received FDA 510(k) clearance on 1988-07-29. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K881815.

When did ABUSCREEN(R) ONTRAK(TM) FOR COCAINE receive FDA 510(k) clearance?

ABUSCREEN(R) ONTRAK(TM) FOR COCAINE received FDA 510(k) clearance on 1988-07-29, under 510(k) number K881815.

Who is the listed applicant for ABUSCREEN(R) ONTRAK(TM) FOR COCAINE?

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) ONTRAK(TM) FOR COCAINE?

The FDA product code for ABUSCREEN(R) ONTRAK(TM) FOR COCAINE is DIO.

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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: DIO)

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.

K213211Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test SystemCarolina Liquid Chemistries Corp.K211973DRI Cocaine Metabolite AssayMicrogenics CorporationK191638Pointe Scientific Cocaine Metabolite Enzyme ImmunoassayMedtest DXK181499DRI Cocaine Metabolite AssayMicrogenics CorporationK170293Emit II Plus Cocaine Metabolite AssaySiemens Healthcare Diagnostics, Inc.K163570Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)Carolina Liquid Chemistries Corporation

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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