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)

GLUCOCARD® W onyx Blood Glucose Monitoring System

K-Number: K183306 · 2019-04-10

ApplicantArkray Factory, Inc.
Decision Date2019-04-10
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOCARD® W onyx Blood Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Arkray Factory, Inc.. It received FDA 510(k) clearance on 2019-04-10 under 510(k) number K183306. 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 GLUCOCARD® W onyx Blood Glucose Monitoring System?

GLUCOCARD® W onyx Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2019-04-10. The listed applicant is Arkray Factory, Inc.. The 510(k) number is K183306.

When did GLUCOCARD® W onyx Blood Glucose Monitoring System receive FDA 510(k) clearance?

GLUCOCARD® W onyx Blood Glucose Monitoring System received FDA 510(k) clearance on 2019-04-10, under 510(k) number K183306.

Who is the listed applicant for GLUCOCARD® W onyx Blood Glucose Monitoring System?

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

What is the FDA product code for GLUCOCARD® W onyx Blood Glucose Monitoring System?

The FDA product code for GLUCOCARD® W onyx Blood Glucose Monitoring System is NBW. This falls under the OB/GYN category.

Other records listing Arkray Factory, 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.

K170064GLUCOCARD W Blood Glucose Monitoring SystemK162822ADAMS A1c HA-8180V, CALIBRATOR 80

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.

↑