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)

CK-UV REAGENT

K-Number: K823211 · 1982-11-22

ApplicantBiorent Diagnostic, Inc.
Decision Date1982-11-22
Product CodeJHS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CK-UV REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Biorent Diagnostic, Inc.. It received FDA 510(k) clearance on 1982-11-22 under 510(k) number K823211. The device is classified under product code JHS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CK-UV REAGENT?

CK-UV REAGENT is a medical device that received FDA 510(k) clearance on 1982-11-22. The listed applicant is Biorent Diagnostic, Inc.. The 510(k) number is K823211.

When did CK-UV REAGENT receive FDA 510(k) clearance?

CK-UV REAGENT received FDA 510(k) clearance on 1982-11-22, under 510(k) number K823211.

Who is the listed applicant for CK-UV REAGENT?

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

What is the FDA product code for CK-UV REAGENT?

The FDA product code for CK-UV REAGENT is JHS.

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 Biorent Diagnostic, 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.

K832747ALBUMIN REAGENT SETK823060HEMOGLOBIN REAGENTK822494OPTIMIZED UV-GPT REAGENT SETK822493OPTIMIZED UV-GOT REAGENT SETK822492OPTIMIZED UV-LDH REAGENT SETK820768COLORIMETRIC LDH REAGENT SET

View all 11 devices →

Related Devices (Code: JHS)

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.

K160570Creatine KinaseRoche Diagnostics Operations (Rdo)K102706CKMB UDR ASSAYSENTINEL CH. SpAK082226S40 CREATINE KINASE (CK)Alfa Wassermann Diagnostic Technologies, Inc.K062128THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYSDade Behring, Inc.K990434CARESIDE CKMBCareside, Inc.K990439CARESIDE CKCareside, 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.

↑