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

FDA 510(k)

Kurin Blood Culture Collection Set with Kurin Lock Technology

K-Number: K220677 · 2023-04-28

ApplicantKurin, Inc.
Decision Date2023-04-28
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Kurin Blood Culture Collection Set with Kurin Lock Technology is a medical device manufactured by Kurin, Inc.. It received FDA 510(k) clearance on 2023-04-28 under approval number K220677. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Kurin Blood Culture Collection Set with Kurin Lock Technology?

Kurin Blood Culture Collection Set with Kurin Lock Technology is a medical device that received FDA 510(k) clearance on 2023-04-28. It is manufactured by Kurin, Inc.. The 510(k) number is K220677.

When was Kurin Blood Culture Collection Set with Kurin Lock Technology approved by the FDA?

Kurin Blood Culture Collection Set with Kurin Lock Technology received FDA 510(k) clearance on 2023-04-28, under approval number K220677.

What company makes Kurin Blood Culture Collection Set with Kurin Lock Technology?

Kurin Blood Culture Collection Set with Kurin Lock Technology is manufactured by Kurin, Inc..

What is the FDA product code for Kurin Blood Culture Collection Set with Kurin Lock Technology?

The FDA product code for Kurin Blood Culture Collection Set with Kurin Lock Technology is JKA.

Related Clinical Trials

NCT01174108 Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-cells RECRUITING NCT03288207 Tailoring Mobile Health Technology to Reduce Obesity and Improve Cardiovascular Health in Resource-Limited Neighborhood Environments RECRUITING NCT07430293 Hybrid Closed-Loop Insulin Delivery After Pancreatectomy RECRUITING NCT06915012 Impact of Biophoton Therapy on Chronic Severe Arthritis Pain RECRUITING NCT07328555 Digital Otoscopy Versus Standard Otoscopy on the Diagnosis and Treatment of Otitis Media in Young Children ACTIVE_NOT_RECRUITING NCT07422623 Hallux Valgus Correction Surgery Recovery Using Semiconductor Embedded Therapeutic Sleeves ENROLLING_BY_INVITATION

Other Devices by Kurin, Inc.

K181895Kurin PIV Blood Collection Set with High Pressure K191832Kurin Blood Culture Collection Set with Kurin Lock Technology, Push-Button Needle (Product models M-21221, M-21223, D-21221, D-21223, T-21221, T-21223)

Related Devices (Code: JKA)

K162233Kurin Blood Culture Collection SetPathway, LLC K160657BD Vacutainer Barricor Lithium Heparin Plasma Blood Collection TubeBecton, Dickinson and Company K153309BD Vacutainer UltraTouch Push Button Blood Collection SetBecton, Dickinson and Company K152924TIVA¿Velano Vascular K163073Sol-Care Safety Blood Collection Needle with and without Pre-Attached HolderSol-Millennium Medical, Inc. K163508PIVOVelano Vascular

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.

↑