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FDA 510(k)

ABUSCREEN(R) ONLINE(TM) FOR AMPHETAMINES, MODIFIED

K-Number: K921998 · 1992-05-26

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1992-05-26
Product CodeDKZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ABUSCREEN(R) ONLINE(TM) FOR AMPHETAMINES, MODIFIED 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 1992-05-26 under 510(k) number K921998. The device is classified under product code DKZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABUSCREEN(R) ONLINE(TM) FOR AMPHETAMINES, MODIFIED?

ABUSCREEN(R) ONLINE(TM) FOR AMPHETAMINES, MODIFIED is a medical device that received FDA 510(k) clearance on 1992-05-26. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K921998.

When did ABUSCREEN(R) ONLINE(TM) FOR AMPHETAMINES, MODIFIED receive FDA 510(k) clearance?

ABUSCREEN(R) ONLINE(TM) FOR AMPHETAMINES, MODIFIED received FDA 510(k) clearance on 1992-05-26, under 510(k) number K921998.

Who is the listed applicant for ABUSCREEN(R) ONLINE(TM) FOR AMPHETAMINES, MODIFIED?

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) ONLINE(TM) FOR AMPHETAMINES, MODIFIED?

The FDA product code for ABUSCREEN(R) ONLINE(TM) FOR AMPHETAMINES, MODIFIED is DKZ.

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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: DKZ)

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

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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