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FDA 510(k)

MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINES

K-Number: K983702 · 1999-02-11

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1999-02-11
Product CodeJXM
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINES 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 1999-02-11 under 510(k) number K983702. The device is classified under product code JXM. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINES?

MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINES is a medical device that received FDA 510(k) clearance on 1999-02-11. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K983702.

When did MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINES receive FDA 510(k) clearance?

MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINES received FDA 510(k) clearance on 1999-02-11, under 510(k) number K983702.

Who is the listed applicant for MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINES?

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 MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINES?

The FDA product code for MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINES is JXM.

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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 BARBITURATESK983704MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINEK983556ABUSCREEN ONLINE BENZ 300 CALIBRATORSK983555ABUSCREEN ONLINE BENZ 200 CALIBRATORSK983700MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENEK983697MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE

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Related Devices (Code: JXM)

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.

K243498Alinity c Benzodiazepines Reagent KitMicrogenics CorporationK221765ONLINE DAT Benzodiazepines IIRoche DiagnosticsK190968CEDIA Benzodiazepine AssayMicrogenics CorporationK173963DRI Benzodiazepine AssayMicrogenics CorporationK163590Psychemedics Microplate EIA for Benzodiazepines in HairPsychemedics CorporationK163704Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip CardHealgen Scientific,, LLC

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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