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FDA 510(k)

ABUSCREEN FP FOR COCAINE METABOLITE

K-Number: K890885 · 1989-03-13

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1989-03-13
Product CodeDIO
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ABUSCREEN FP 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 1989-03-13 under 510(k) number K890885. 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 FP FOR COCAINE METABOLITE?

ABUSCREEN FP FOR COCAINE METABOLITE is a medical device that received FDA 510(k) clearance on 1989-03-13. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K890885.

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

ABUSCREEN FP FOR COCAINE METABOLITE received FDA 510(k) clearance on 1989-03-13, under 510(k) number K890885.

Who is the listed applicant for ABUSCREEN FP 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 FP FOR COCAINE METABOLITE?

The FDA product code for ABUSCREEN FP FOR COCAINE METABOLITE is DIO.

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Other records listing Roche Diagnostic Systems, Inc. as applicant

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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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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