Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

UNIPAK URIC ACID

K-Number: K771088 · 1977-07-21

ApplicantHarleco
Decision Date1977-07-21
Product CodeKNK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

UNIPAK URIC ACID is the device name listed in this FDA 510(k) record. The listed applicant is Harleco. It received FDA 510(k) clearance on 1977-07-21 under 510(k) number K771088. 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 UNIPAK URIC ACID?

UNIPAK URIC ACID is a medical device that received FDA 510(k) clearance on 1977-07-21. The listed applicant is Harleco. The 510(k) number is K771088.

When did UNIPAK URIC ACID receive FDA 510(k) clearance?

UNIPAK URIC ACID received FDA 510(k) clearance on 1977-07-21, under 510(k) number K771088.

Who is the listed applicant for UNIPAK URIC ACID?

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 UNIPAK URIC ACID?

The FDA product code for UNIPAK URIC ACID is KNK.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

View all 116 devices →

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.

↑