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)

ReliOn Premier Classic Blood Glucose Monitoring System

K-Number: K192220 · 2019-12-13

ApplicantI-Sens, Inc.
Decision Date2019-12-13
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ReliOn Premier Classic Blood Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is I-Sens, Inc.. It received FDA 510(k) clearance on 2019-12-13 under 510(k) number K192220. The device is classified under product code NBW. It was reviewed by the CH advisory panel. Product code NBW falls under the category of OB/GYN, which includes obstetric and gynecological diagnostic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ReliOn Premier Classic Blood Glucose Monitoring System?

ReliOn Premier Classic Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2019-12-13. The listed applicant is I-Sens, Inc.. The 510(k) number is K192220.

When did ReliOn Premier Classic Blood Glucose Monitoring System receive FDA 510(k) clearance?

ReliOn Premier Classic Blood Glucose Monitoring System received FDA 510(k) clearance on 2019-12-13, under 510(k) number K192220.

Who is the listed applicant for ReliOn Premier Classic Blood Glucose Monitoring System?

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

What is the FDA product code for ReliOn Premier Classic Blood Glucose Monitoring System?

The FDA product code for ReliOn Premier Classic Blood Glucose Monitoring System is NBW. This falls under the OB/GYN category.

Other records listing I-Sens, 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.

K230625ReliOn Premier BLU Blood Glucose Monitoring SystemK222656LDE4 Lancing DeviceK201394CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring SystemK201551KetoSens BT Blood B-Ketone Monitoring SystemK192859CareSens S Clear BT Blood Glucose Monitoring SystemK193590CareSens S Fit BT Blood Glucose Monitoring System

View all 13 devices →

Related Devices (Code: NBW)

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.

K262116TRUE METRIX Self Monitoring Blood Glucose SystemTrividia Health, Inc.K250085On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring SystemACON Laboratories, Inc.K243060TeleRPM Gen2 Blood Glucose Monitoring SystemGuangdong Transtek Medical Electronics Co., Ltd.K240637RIGHTEST Blood Glucose Monitoring System Max TelBionime CorporationK240640Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring SystemSejoy Biomedical Co., Ltd.K241787CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring SystemAscensia Diabetes Care U.S., 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.

↑