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FDA 510(k)

A-GENT PHENOBARBITAL

K-Number: K832457 · 1983-09-12

ApplicantAbbott Laboratories
Decision Date1983-09-12
Product CodeDLZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

A-GENT PHENOBARBITAL is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1983-09-12 under 510(k) number K832457. 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 A-GENT PHENOBARBITAL?

A-GENT PHENOBARBITAL is a medical device that received FDA 510(k) clearance on 1983-09-12. The listed applicant is Abbott Laboratories. The 510(k) number is K832457.

When did A-GENT PHENOBARBITAL receive FDA 510(k) clearance?

A-GENT PHENOBARBITAL received FDA 510(k) clearance on 1983-09-12, under 510(k) number K832457.

Who is the listed applicant for A-GENT PHENOBARBITAL?

The FDA 510(k) record lists Abbott Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for A-GENT PHENOBARBITAL?

The FDA product code for A-GENT PHENOBARBITAL is DLZ.

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Related Devices (Code: DLZ)

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.

K210858VITROS Chemistry Products PHBR SlidesOrtho-Clinical Diagnostics, Inc.K123271ABBOTT PHENOBARBITAL ASSAYMicrogenics Corp.K081231ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS, MODELS 1P33, 1P33Abbott LaboratoriesK071644ONLINE 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.

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