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FDA 510(k)

PHENOBARBITAL TEST SYSTEM

K-Number: K860365 · 1986-03-17

ApplicantAllied Instrumentation Laboratory
Decision Date1986-03-17
Product CodeDLZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

PHENOBARBITAL TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Allied Instrumentation Laboratory. It received FDA 510(k) clearance on 1986-03-17 under 510(k) number K860365. 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 PHENOBARBITAL TEST SYSTEM?

PHENOBARBITAL TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1986-03-17. The listed applicant is Allied Instrumentation Laboratory. The 510(k) number is K860365.

When did PHENOBARBITAL TEST SYSTEM receive FDA 510(k) clearance?

PHENOBARBITAL TEST SYSTEM received FDA 510(k) clearance on 1986-03-17, under 510(k) number K860365.

Who is the listed applicant for PHENOBARBITAL TEST SYSTEM?

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

What is the FDA product code for PHENOBARBITAL TEST SYSTEM?

The FDA product code for PHENOBARBITAL TEST SYSTEM is DLZ.

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Other records listing Allied Instrumentation Laboratory as applicant

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.

K861901MULTI-4 CO-OXIMETER CONTROLK860286IL TEST PHENYTOINK853858IL TEST THEOPHYLLINE ASSAYK852676IL SYSTEM 1304 & 1306, PH/BLOOD GAS ANALYZERSK851933CLINICAL CHEMISTRY ANALYTICAL SYSTEMK850748I-L TEST, DIRECT BILIRUBIN SET

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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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