FDA 510(k)

ABUSCREEN ONLINE II FOR OPIATES 300/2000, ABUSCREEN ONLINE OPIATES CALIBRATION PACK, ABUSCREEN ONLINE OPIATES CONTROL

K-Number: K974840 · 1998-04-24

Decision Date1998-04-24

Product CodeDJG

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

ABUSCREEN ONLINE II FOR OPIATES 300/2000, ABUSCREEN ONLINE OPIATES CALIBRATION PACK, ABUSCREEN ONLINE OPIATES CONTROL 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 1998-04-24 under 510(k) number K974840. 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 II FOR OPIATES 300/2000, ABUSCREEN ONLINE OPIATES CALIBRATION PACK, ABUSCREEN ONLINE OPIATES CONTROL?

ABUSCREEN ONLINE II FOR OPIATES 300/2000, ABUSCREEN ONLINE OPIATES CALIBRATION PACK, ABUSCREEN ONLINE OPIATES CONTROL is a medical device that received FDA 510(k) clearance on 1998-04-24. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K974840.

When did ABUSCREEN ONLINE II FOR OPIATES 300/2000, ABUSCREEN ONLINE OPIATES CALIBRATION PACK, ABUSCREEN ONLINE OPIATES CONTROL receive FDA 510(k) clearance?

ABUSCREEN ONLINE II FOR OPIATES 300/2000, ABUSCREEN ONLINE OPIATES CALIBRATION PACK, ABUSCREEN ONLINE OPIATES CONTROL received FDA 510(k) clearance on 1998-04-24, under 510(k) number K974840.

Who is the listed applicant for ABUSCREEN ONLINE II FOR OPIATES 300/2000, ABUSCREEN ONLINE OPIATES CALIBRATION PACK, ABUSCREEN ONLINE OPIATES CONTROL?

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 II FOR OPIATES 300/2000, ABUSCREEN ONLINE OPIATES CALIBRATION PACK, ABUSCREEN ONLINE OPIATES CONTROL?

The FDA product code for ABUSCREEN ONLINE II FOR OPIATES 300/2000, ABUSCREEN ONLINE OPIATES CALIBRATION PACK, ABUSCREEN ONLINE OPIATES CONTROL is DJG.

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Other records listing Roche Diagnostic Systems, Inc. as applicant

K983698MODIFICATION TO ABUSCREEN ONLINE BARBITURATES K983702MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINES K983704MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE K983556ABUSCREEN ONLINE BENZ 300 CALIBRATORS K983555ABUSCREEN ONLINE BENZ 200 CALIBRATORS K983700MODIFICATION 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.