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FDA 510(k)

MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE

K-Number: K983697 · 1998-12-11

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1998-12-11
Product CodeDIO
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO ABUSCREEN ONLINE 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 1998-12-11 under 510(k) number K983697. 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 MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE?

MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE is a medical device that received FDA 510(k) clearance on 1998-12-11. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K983697.

When did MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE receive FDA 510(k) clearance?

MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE received FDA 510(k) clearance on 1998-12-11, under 510(k) number K983697.

Who is the listed applicant for MODIFICATION TO ABUSCREEN ONLINE 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 MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE?

The FDA product code for MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE 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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