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FDA 510(k)

ABUSCREEN RADIOIMMUNOASSAY FOR CANNABI

K-Number: K820391 · 1982-03-08

ApplicantHoffmann-La Roche, Inc.
Decision Date1982-03-08
Product CodeLAT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ABUSCREEN RADIOIMMUNOASSAY FOR CANNABI is the device name listed in this FDA 510(k) record. The listed applicant is Hoffmann-La Roche, Inc.. It received FDA 510(k) clearance on 1982-03-08 under 510(k) number K820391. The device is classified under product code LAT. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABUSCREEN RADIOIMMUNOASSAY FOR CANNABI?

ABUSCREEN RADIOIMMUNOASSAY FOR CANNABI is a medical device that received FDA 510(k) clearance on 1982-03-08. The listed applicant is Hoffmann-La Roche, Inc.. The 510(k) number is K820391.

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

ABUSCREEN RADIOIMMUNOASSAY FOR CANNABI received FDA 510(k) clearance on 1982-03-08, under 510(k) number K820391.

Who is the listed applicant for ABUSCREEN RADIOIMMUNOASSAY FOR CANNABI?

The FDA 510(k) record lists Hoffmann-La Roche, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ABUSCREEN RADIOIMMUNOASSAY FOR CANNABI?

The FDA product code for ABUSCREEN RADIOIMMUNOASSAY FOR CANNABI is LAT.

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Other records listing Hoffmann-La Roche, 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.

K850727BHCG-ROCHE EIAK831694RENAKK830462ABUSCREEN RADIOUMMUNOASSAY--URINEK830480ABUSCREEN RADIOIMMUNOASSAY-COCAINE METAK830482ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINEK830461ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE

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Related Devices (Code: LAT)

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.

K011426PSYCHEMEDICS RIA CANNABINOID ASSAYPsychemedics Corp.K961620ABISCREEN ONLINE FOR CANNABINOIDS - ES 50/100Roche Diagnostic Systems, Inc.K936135SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF MARIJUANA IN PERSPIRATIONSudormed, Inc.K914507DOUBLE ANTIBODY CANNABIONOIDS/QUAIL DETER IN URINEDiagnostic Products Corp.K913414ABUSCREEN(R) ONLINE(TM) FOR THC(50/100)(100TEST KTRoche Diagnostic Systems, Inc.K913865URINE THC DIRECT RIA KIT (I-125)Immunalysis Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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