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FDA 510(k)

UN(UREASE)REAGENT UN(A-KETO)REAGENT

K-Number: K851991 · 1985-05-29

ApplicantAlpkem Corp.
Decision Date1985-05-29
Product CodeKNK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

UN(UREASE)REAGENT UN(A-KETO)REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Alpkem Corp.. It received FDA 510(k) clearance on 1985-05-29 under 510(k) number K851991. The device is classified under product code KNK. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UN(UREASE)REAGENT UN(A-KETO)REAGENT?

UN(UREASE)REAGENT UN(A-KETO)REAGENT is a medical device that received FDA 510(k) clearance on 1985-05-29. The listed applicant is Alpkem Corp.. The 510(k) number is K851991.

When did UN(UREASE)REAGENT UN(A-KETO)REAGENT receive FDA 510(k) clearance?

UN(UREASE)REAGENT UN(A-KETO)REAGENT received FDA 510(k) clearance on 1985-05-29, under 510(k) number K851991.

Who is the listed applicant for UN(UREASE)REAGENT UN(A-KETO)REAGENT?

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

What is the FDA product code for UN(UREASE)REAGENT UN(A-KETO)REAGENT?

The FDA product code for UN(UREASE)REAGENT UN(A-KETO)REAGENT is KNK.

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Other records listing Alpkem Corp. 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.

K894011TOTAL GALACTOSEK891070PHENYLALANINE (NINHYDRIN REACTION)K890334TOTAL CHOLESTEROL REAGENTK890337TRIGLYCERIDES - GPO REAGENTK890336GLUCOSE (GOD) REAGENTK890332RFA/2 RAPID FLOW ANALYZER W/COMPUTER

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Related Devices (Code: KNK)

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.

K102568URIC ACID MODEL 3P39Abbott LaboratoriesK062862OLYMPUS URIC ACID REAGENT, MODEL OSR6X98Olympus America, Inc.K040467VITALAB URIC ACID REAGENTClinical Data, Inc.K031044ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATORClinical Data, Inc.K022096URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEMBayer Diagnostics Corp.K023550WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDAWiener Laboratories Saic

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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