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FDA 510(k)

AGGLUTEX AMPHETAMINE TEST KIT

K-Number: K812986 · 1982-01-22

ApplicantHoffmann-La Roche, Inc.
Decision Date1982-01-22
Product CodeDJP
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

AGGLUTEX AMPHETAMINE TEST KIT 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 1982-01-22 under 510(k) number K812986. The device is classified under product code DJP. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AGGLUTEX AMPHETAMINE TEST KIT?

AGGLUTEX AMPHETAMINE TEST KIT is a medical device that received FDA 510(k) clearance on 1982-01-22. The listed applicant is Hoffmann-La Roche, Inc.. The 510(k) number is K812986.

When did AGGLUTEX AMPHETAMINE TEST KIT receive FDA 510(k) clearance?

AGGLUTEX AMPHETAMINE TEST KIT received FDA 510(k) clearance on 1982-01-22, under 510(k) number K812986.

Who is the listed applicant for AGGLUTEX AMPHETAMINE TEST KIT?

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 AGGLUTEX AMPHETAMINE TEST KIT?

The FDA product code for AGGLUTEX AMPHETAMINE TEST KIT is DJP.

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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: DJP)

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.

K960526PRIMIDONE EIA TESTDiagnostic Reagents, Inc.K913866URINE AMPHETAMINE DIRECT RIA KIT (I-125)Immunalysis CorporationK912755ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINERoche Diagnostic Systems, Inc.K882228REVISED DOUBLE ANTIBODY AMPHETAMINEDiagnostic Products Corp.K881817ABUSCREEN(R) ONTRAK(TM) FOR AMPHETAMINESRoche Diagnostic Systems, Inc.K854009ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE-HIGH SPRoche Diagnostic Systems, Inc.

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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