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FDA 510(k)

ABUSCREEN RADIOIMMUNOASSAY FOR CANNABINIODS

K-Number: K912757 · 1991-07-26

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1991-07-26
Product CodeLDJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ABUSCREEN RADIOIMMUNOASSAY FOR CANNABINIODS 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 1991-07-26 under 510(k) number K912757. 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 RADIOIMMUNOASSAY FOR CANNABINIODS?

ABUSCREEN RADIOIMMUNOASSAY FOR CANNABINIODS is a medical device that received FDA 510(k) clearance on 1991-07-26. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K912757.

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

ABUSCREEN RADIOIMMUNOASSAY FOR CANNABINIODS received FDA 510(k) clearance on 1991-07-26, under 510(k) number K912757.

Who is the listed applicant for ABUSCREEN RADIOIMMUNOASSAY FOR CANNABINIODS?

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 CANNABINIODS?

The FDA product code for ABUSCREEN RADIOIMMUNOASSAY FOR CANNABINIODS 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.

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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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