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FDA 510(k)

ABUSCREEN RADIOIMMUNOASSAY FOR BENZODIAZEPINES

K-Number: K870994 · 1987-03-24

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1987-03-24
Product CodeJXM
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ABUSCREEN RADIOIMMUNOASSAY FOR BENZODIAZEPINES 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 1987-03-24 under 510(k) number K870994. 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 ABUSCREEN RADIOIMMUNOASSAY FOR BENZODIAZEPINES?

ABUSCREEN RADIOIMMUNOASSAY FOR BENZODIAZEPINES is a medical device that received FDA 510(k) clearance on 1987-03-24. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K870994.

When did ABUSCREEN RADIOIMMUNOASSAY FOR BENZODIAZEPINES receive FDA 510(k) clearance?

ABUSCREEN RADIOIMMUNOASSAY FOR BENZODIAZEPINES received FDA 510(k) clearance on 1987-03-24, under 510(k) number K870994.

Who is the listed applicant for ABUSCREEN RADIOIMMUNOASSAY FOR BENZODIAZEPINES?

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 RADIOIMMUNOASSAY FOR BENZODIAZEPINES?

The FDA product code for ABUSCREEN RADIOIMMUNOASSAY FOR BENZODIAZEPINES 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 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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