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FDA 510(k)

PHENYTOIN REAGENT TEST KIT

K-Number: K802038 · 1980-10-23

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

Device Summary

PHENYTOIN 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 K802038. The device is classified under product code DID. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHENYTOIN REAGENT TEST KIT?

PHENYTOIN 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 K802038.

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

PHENYTOIN REAGENT TEST KIT received FDA 510(k) clearance on 1980-10-23, under 510(k) number K802038.

Who is the listed applicant for PHENYTOIN 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 PHENYTOIN REAGENT TEST KIT?

The FDA product code for PHENYTOIN REAGENT TEST KIT is DID.

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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: DID)

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.

K820773EMIT-ST URINE COCAINE METABOLITE ASSAYSyva Co.K780950BIO-MONITOR TOBRAMYCINMonitor Science Corp.K780182TOBRAMYCIN 125I RIA KITNew England NuclearK780048AMINOGLYCOSIDE TEST SYSTEMNichols Institute Diagnostics

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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