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)

WORTHINGTON CK (NAC) REAGENT SET

K-Number: K810997 · 1981-04-23

ApplicantWorthington Diagnostic Systems
Decision Date1981-04-23
Product CodeJHS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

WORTHINGTON CK (NAC) REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Worthington Diagnostic Systems. It received FDA 510(k) clearance on 1981-04-23 under 510(k) number K810997. 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 WORTHINGTON CK (NAC) REAGENT SET?

WORTHINGTON CK (NAC) REAGENT SET is a medical device that received FDA 510(k) clearance on 1981-04-23. The listed applicant is Worthington Diagnostic Systems. The 510(k) number is K810997.

When did WORTHINGTON CK (NAC) REAGENT SET receive FDA 510(k) clearance?

WORTHINGTON CK (NAC) REAGENT SET received FDA 510(k) clearance on 1981-04-23, under 510(k) number K810997.

Who is the listed applicant for WORTHINGTON CK (NAC) REAGENT SET?

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

What is the FDA product code for WORTHINGTON CK (NAC) REAGENT SET?

The FDA product code for WORTHINGTON CK (NAC) REAGENT SET 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 Worthington Diagnostic Systems 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.

K833708COMPUR* M1000 HEMOGLOBIN & ERYTHROCYTEK832748COMPUR* EASYTOUCH TOTAL BILIRUBINK832785COMPUR* EASY TOUCH URIC ACID REAGENTK832427EASYTOUCH TROMBOPLASTIN REAGENTK832749EASYTOUCH BUN REAGENT SETK832750EASYTOUCH HEMOGLOBIN REAGENT

View all 19 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.

↑