FDA 510(k)

AGGLUTEX BARBITURATES TEST KIT

K-Number: K812988 · 1981-12-31

Decision Date1981-12-31

Product CodeDKN

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

AGGLUTEX BARBITURATES 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 1981-12-31 under 510(k) number K812988. 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 AGGLUTEX BARBITURATES TEST KIT?

AGGLUTEX BARBITURATES TEST KIT is a medical device that received FDA 510(k) clearance on 1981-12-31. The listed applicant is Hoffmann-La Roche, Inc.. The 510(k) number is K812988.

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

AGGLUTEX BARBITURATES TEST KIT received FDA 510(k) clearance on 1981-12-31, under 510(k) number K812988.

Who is the listed applicant for AGGLUTEX BARBITURATES 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 BARBITURATES TEST KIT?

The FDA product code for AGGLUTEX BARBITURATES TEST KIT is DKN.

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Other records listing Hoffmann-La Roche, Inc. as applicant

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Related Devices (Code: DKN)

K914468ABUSCREEN(R) ONLINE(TM) FOR BARBITURATESRoche Diagnostic Systems, Inc.K881816ABUSCREEN(R) ONTRAK(TM) FOR BARBITURATESRoche Diagnostic Systems, Inc.K830479ABUSCREEN RADIOIMMUNOASSAY-BARBITURATEHoffmann-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.