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FDA 510(k)

AGGLUTEX MORPHINE TEST KIT

K-Number: K812985 · 1981-12-31

ApplicantHoffmann-La Roche, Inc.
Decision Date1981-12-31
Product CodeDDF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

AGGLUTEX MORPHINE 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 K812985. The device is classified under product code DDF. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AGGLUTEX MORPHINE TEST KIT?

AGGLUTEX MORPHINE 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 K812985.

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

AGGLUTEX MORPHINE TEST KIT received FDA 510(k) clearance on 1981-12-31, under 510(k) number K812985.

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

The FDA product code for AGGLUTEX MORPHINE TEST KIT is DDF.

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

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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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