FDA 510(k)

DETERMINATION OF PHENOBARBITAL

K-Number: K860046 · 1986-01-22

Decision Date1986-01-22

Product CodeDLZ

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

DETERMINATION OF PHENOBARBITAL is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Data, Inc.. It received FDA 510(k) clearance on 1986-01-22 under 510(k) number K860046. The device is classified under product code DLZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DETERMINATION OF PHENOBARBITAL?

DETERMINATION OF PHENOBARBITAL is a medical device that received FDA 510(k) clearance on 1986-01-22. The listed applicant is Clinical Data, Inc.. The 510(k) number is K860046.

When did DETERMINATION OF PHENOBARBITAL receive FDA 510(k) clearance?

DETERMINATION OF PHENOBARBITAL received FDA 510(k) clearance on 1986-01-22, under 510(k) number K860046.

Who is the listed applicant for DETERMINATION OF PHENOBARBITAL?

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

What is the FDA product code for DETERMINATION OF PHENOBARBITAL?

The FDA product code for DETERMINATION OF PHENOBARBITAL is DLZ.

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Related Devices (Code: DLZ)

K210858VITROS Chemistry Products PHBR SlidesOrtho-Clinical Diagnostics, Inc.K123271ABBOTT PHENOBARBITAL ASSAYMicrogenics Corp.K081231ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS, MODELS 1P33, 1P33Abbott Laboratories K071644ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620Roche Diagnostics Corp.K011303RANDOX PHENOBARBITALRandox Laboratories, Ltd.K011528EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229Syva Co.

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.