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FDA 510(k)

RANDOX PHENOBARBITAL

K-Number: K011303 · 2001-07-02

ApplicantRandox Laboratories, Ltd.
Decision Date2001-07-02
Product CodeDLZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

RANDOX PHENOBARBITAL is the device name listed in this FDA 510(k) record. The listed applicant is Randox Laboratories, Ltd.. It received FDA 510(k) clearance on 2001-07-02 under 510(k) number K011303. 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 RANDOX PHENOBARBITAL?

RANDOX PHENOBARBITAL is a medical device that received FDA 510(k) clearance on 2001-07-02. The listed applicant is Randox Laboratories, Ltd.. The 510(k) number is K011303.

When did RANDOX PHENOBARBITAL receive FDA 510(k) clearance?

RANDOX PHENOBARBITAL received FDA 510(k) clearance on 2001-07-02, under 510(k) number K011303.

Who is the listed applicant for RANDOX PHENOBARBITAL?

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

What is the FDA product code for RANDOX PHENOBARBITAL?

The FDA product code for RANDOX PHENOBARBITAL is DLZ.

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Other records listing Randox Laboratories, Ltd. as applicant

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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.K011528EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229Syva Co.K000012IMMULITE PHENOBARBITAL, MODELS LKPB1, LKPB5Diagnostic Products Corp.

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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