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FDA 510(k)

PHENOBARBITAL REAGENT TEST KIT

K-Number: K802039 · 1980-10-23

ApplicantBeckman Instruments, Inc.
Decision Date1980-10-23
Product CodeDLZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

PHENOBARBITAL REAGENT TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Instruments, Inc.. It received FDA 510(k) clearance on 1980-10-23 under 510(k) number K802039. 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 REAGENT TEST KIT?

PHENOBARBITAL REAGENT TEST KIT is a medical device that received FDA 510(k) clearance on 1980-10-23. The listed applicant is Beckman Instruments, Inc.. The 510(k) number is K802039.

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

PHENOBARBITAL REAGENT TEST KIT received FDA 510(k) clearance on 1980-10-23, under 510(k) number K802039.

Who is the listed applicant for PHENOBARBITAL REAGENT TEST KIT?

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

What is the FDA product code for PHENOBARBITAL REAGENT TEST KIT?

The FDA product code for PHENOBARBITAL REAGENT TEST KIT is DLZ.

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Other records listing Beckman Instruments, Inc. 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.

K973448ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469K982250ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZERK981403IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENTK981354ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211K980173ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505K974816ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229

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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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