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FDA 510(k)

COCAINE METABOLITE ROCHE(R) EIA

K-Number: K863843 · 1987-03-16

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1987-03-16
Product CodeDIO
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

COCAINE METABOLITE ROCHE(R) EIA is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1987-03-16 under 510(k) number K863843. The device is classified under product code DIO. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COCAINE METABOLITE ROCHE(R) EIA?

COCAINE METABOLITE ROCHE(R) EIA is a medical device that received FDA 510(k) clearance on 1987-03-16. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K863843.

When did COCAINE METABOLITE ROCHE(R) EIA receive FDA 510(k) clearance?

COCAINE METABOLITE ROCHE(R) EIA received FDA 510(k) clearance on 1987-03-16, under 510(k) number K863843.

Who is the listed applicant for COCAINE METABOLITE ROCHE(R) EIA?

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

What is the FDA product code for COCAINE METABOLITE ROCHE(R) EIA?

The FDA product code for COCAINE METABOLITE ROCHE(R) EIA is DIO.

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Related Devices (Code: DIO)

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.

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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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