Glucose Shepherd Blood Glucose Monitoring System

FDA 510(k) K102316 · Broadmaster Biotech Corporation

Substantially Equivalent

510(k) numberK102316

Submission

Device name
Glucose Shepherd Blood Glucose Monitoring System
Applicant
Broadmaster Biotech Corporation
Zhonghe City, TW
Received
August 16, 2010
Decision date
October 7, 2011
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
CGA – Glucose Oxidase, Glucose
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1345
Specialty
Clinical Chemistry

Other 510(k)s with product code CGA

510(k)DeviceApplicantDecision
K252488ABL90 FLEX PLUS SystemCGA · Traditional Radiometer Medicals Aps05/01/2026SE
K210933YSI 2900C Biochemistry AnalyzerCGA · Traditional Ysi, Inc.09/30/2024SE
K220328EasyStat 300CGA · Traditional Medica Corporation07/26/2024SE
K223179Cholestech LDX ™ SystemCGA · Dual Track Alere San Diego, Inc.09/20/2023SE
K223755i-STAT G cartridge with the i-STAT 1 SystemCGA · Traditional Abbott Point of Care, Inc.09/11/2023SE
K223710i-STAT CG8+ cartridge with the i-STAT 1 SystemCGA · Traditional Abbott Point of Care, Inc.07/28/2023SE
K223090GEM Premier ChemSTATCGA · Special Instrumentation Laboratory CO01/27/2023SE
K203549Nova Primary Glucose Analyzer SystemCGA · Traditional Nova Biomedical Corporation10/18/2022SE
K210958i-STAT CHEM8+ cartridge with the i-STAT 1 SystemCGA · Traditional Abbott Point of Care, Inc.08/13/2021SE
K200349Stat Profile Prime Plus Analyzer SystemCGA · Traditional Nova Biomedical Corporation03/13/2020SE

More from Nova Biomedical Corporation

510(k)DeviceDecision
K191004Advocate Non-Contact Infrared ThermometerFLL · Traditional 09/05/2019SE
K180355Advocate Non-Contact Infrared ThermometerFLL · Traditional 01/10/2019SE
K130621Broadmaster Healthcare SystemNBW · Traditional 07/30/2013SE

Questions and answers

When was Glucose Shepherd Blood Glucose Monitoring System cleared by the FDA?

Glucose Shepherd Blood Glucose Monitoring System (K102316) received a 510(k) decision of Substantially Equivalent on October 7, 2011, 417 days after the submission was received.

What is the product code of K102316?

The FDA product code is CGA – Glucose Oxidase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.