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FDA 510(k)

ABUSCREEN ONLINE TM FOR OPIATES

K-Number: K904997 · 1990-12-27

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1990-12-27
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ABUSCREEN ONLINE TM FOR OPIATES 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 1990-12-27 under 510(k) number K904997. The device is classified under product code DJG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABUSCREEN ONLINE TM FOR OPIATES?

ABUSCREEN ONLINE TM FOR OPIATES is a medical device that received FDA 510(k) clearance on 1990-12-27. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K904997.

When did ABUSCREEN ONLINE TM FOR OPIATES receive FDA 510(k) clearance?

ABUSCREEN ONLINE TM FOR OPIATES received FDA 510(k) clearance on 1990-12-27, under 510(k) number K904997.

Who is the listed applicant for ABUSCREEN ONLINE TM FOR OPIATES?

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 TM FOR OPIATES?

The FDA product code for ABUSCREEN ONLINE TM FOR OPIATES is DJG.

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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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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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