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FDA 510(k)

ULTRACHEM URIC ACID ALDH, ITEM #65047

K-Number: K812500 · 1981-09-23

ApplicantHarleco
Decision Date1981-09-23
Product CodeCDO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ULTRACHEM URIC ACID ALDH, ITEM #65047 is the device name listed in this FDA 510(k) record. The listed applicant is Harleco. It received FDA 510(k) clearance on 1981-09-23 under 510(k) number K812500. The device is classified under product code CDO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRACHEM URIC ACID ALDH, ITEM #65047?

ULTRACHEM URIC ACID ALDH, ITEM #65047 is a medical device that received FDA 510(k) clearance on 1981-09-23. The listed applicant is Harleco. The 510(k) number is K812500.

When did ULTRACHEM URIC ACID ALDH, ITEM #65047 receive FDA 510(k) clearance?

ULTRACHEM URIC ACID ALDH, ITEM #65047 received FDA 510(k) clearance on 1981-09-23, under 510(k) number K812500.

Who is the listed applicant for ULTRACHEM URIC ACID ALDH, ITEM #65047?

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

What is the FDA product code for ULTRACHEM URIC ACID ALDH, ITEM #65047?

The FDA product code for ULTRACHEM URIC ACID ALDH, ITEM #65047 is CDO.

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Other records listing Harleco 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.

K820233ULTRAZYME PLUS GAMMA GT(65055-65056)K813427ULTRACHEM GLUC-DHK813038ULTRACHEM TP, ITEM #64974K813041ULTRAZYME-GT, ITEM #64959 & 65032K813042ULTRACHEM GLUC-DH SET, ITEM #65048K813044ULTRACHEM ALB, ITEM #64970

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Related Devices (Code: CDO)

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.

K033278RANDOX URIC ACIDRandox Laboratories, Ltd.K992798SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P, 684-500P, 684-2000P, 683-20, 683-100PSigma Diagnostics, Inc.K982251SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KITSigma Diagnostics, Inc.K981766URIC ACIDAbbott LaboratoriesK981189URIC ACIDAbbott LaboratoriesK971485URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)Trace America, Inc.

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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