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FDA 510(k)

ABUSCREEN ONLINE(R) FOR COCAINE METABOLITE, MODIF

K-Number: K933053 · 1993-08-30

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1993-08-30
Product CodeDIO
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ABUSCREEN ONLINE(R) FOR COCAINE METABOLITE, MODIF 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 1993-08-30 under 510(k) number K933053. 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 ONLINE(R) FOR COCAINE METABOLITE, MODIF?

ABUSCREEN ONLINE(R) FOR COCAINE METABOLITE, MODIF is a medical device that received FDA 510(k) clearance on 1993-08-30. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K933053.

When did ABUSCREEN ONLINE(R) FOR COCAINE METABOLITE, MODIF receive FDA 510(k) clearance?

ABUSCREEN ONLINE(R) FOR COCAINE METABOLITE, MODIF received FDA 510(k) clearance on 1993-08-30, under 510(k) number K933053.

Who is the listed applicant for ABUSCREEN ONLINE(R) FOR COCAINE METABOLITE, MODIF?

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(R) FOR COCAINE METABOLITE, MODIF?

The FDA product code for ABUSCREEN ONLINE(R) FOR COCAINE METABOLITE, MODIF 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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