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FDA 510(k)

ABUSCREEN ONLINE FOR CANNABINOIDS (100 TEST KIT)

K-Number: K981584 · 1998-05-28

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1998-05-28
Product CodeLDJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ABUSCREEN ONLINE FOR CANNABINOIDS (100 TEST KIT) 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 1998-05-28 under 510(k) number K981584. The device is classified under product code LDJ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABUSCREEN ONLINE FOR CANNABINOIDS (100 TEST KIT)?

ABUSCREEN ONLINE FOR CANNABINOIDS (100 TEST KIT) is a medical device that received FDA 510(k) clearance on 1998-05-28. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K981584.

When did ABUSCREEN ONLINE FOR CANNABINOIDS (100 TEST KIT) receive FDA 510(k) clearance?

ABUSCREEN ONLINE FOR CANNABINOIDS (100 TEST KIT) received FDA 510(k) clearance on 1998-05-28, under 510(k) number K981584.

Who is the listed applicant for ABUSCREEN ONLINE FOR CANNABINOIDS (100 TEST KIT)?

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 FOR CANNABINOIDS (100 TEST KIT)?

The FDA product code for ABUSCREEN ONLINE FOR CANNABINOIDS (100 TEST KIT) is LDJ.

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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

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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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