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FDA 510(k)

ABUSCREEN RADIOIMMUNOASSAY-BARBITURATE

K-Number: K830479 · 1983-03-10

ApplicantHoffmann-La Roche, Inc.
Decision Date1983-03-10
Product CodeDKN
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ABUSCREEN RADIOIMMUNOASSAY-BARBITURATE 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 1983-03-10 under 510(k) number K830479. The device is classified under product code DKN. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABUSCREEN RADIOIMMUNOASSAY-BARBITURATE?

ABUSCREEN RADIOIMMUNOASSAY-BARBITURATE is a medical device that received FDA 510(k) clearance on 1983-03-10. The listed applicant is Hoffmann-La Roche, Inc.. The 510(k) number is K830479.

When did ABUSCREEN RADIOIMMUNOASSAY-BARBITURATE receive FDA 510(k) clearance?

ABUSCREEN RADIOIMMUNOASSAY-BARBITURATE received FDA 510(k) clearance on 1983-03-10, under 510(k) number K830479.

Who is the listed applicant for ABUSCREEN RADIOIMMUNOASSAY-BARBITURATE?

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-BARBITURATE?

The FDA product code for ABUSCREEN RADIOIMMUNOASSAY-BARBITURATE is DKN.

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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: DKN)

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.

K914468ABUSCREEN(R) ONLINE(TM) FOR BARBITURATESRoche Diagnostic Systems, Inc.K881816ABUSCREEN(R) ONTRAK(TM) FOR BARBITURATESRoche Diagnostic Systems, Inc.K812988AGGLUTEX BARBITURATES TEST KITHoffmann-La Roche, 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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