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FDA 510(k)

MAJOR III BLOOD GLUCOSE MONITORING SYSTEM

K-Number: K072274 · 2008-02-29

ApplicantBestgen Biotech Corp.
Decision Date2008-02-29
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MAJOR III BLOOD GLUCOSE MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bestgen Biotech Corp.. It received FDA 510(k) clearance on 2008-02-29 under 510(k) number K072274. 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 MAJOR III BLOOD GLUCOSE MONITORING SYSTEM?

MAJOR III BLOOD GLUCOSE MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2008-02-29. The listed applicant is Bestgen Biotech Corp.. The 510(k) number is K072274.

When did MAJOR III BLOOD GLUCOSE MONITORING SYSTEM receive FDA 510(k) clearance?

MAJOR III BLOOD GLUCOSE MONITORING SYSTEM received FDA 510(k) clearance on 2008-02-29, under 510(k) number K072274.

Who is the listed applicant for MAJOR III BLOOD GLUCOSE MONITORING SYSTEM?

The FDA 510(k) record lists Bestgen Biotech Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAJOR III BLOOD GLUCOSE MONITORING SYSTEM?

The FDA product code for MAJOR III BLOOD GLUCOSE MONITORING SYSTEM is NBW. This falls under the OB/GYN category.

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Other records listing Bestgen Biotech Corp. 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.

K103230AP-3000 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTIONK103116AP-2000, AP-2010, AND AP-2020 BLOOD GLUCOSE MONITORING SYSTEMK103044AP-1010 AND AP-1020 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTIONK100437AP-1000 BLOOD GLUCOSE MONITORING SYSTEM, MODEL AP-1000, MAJOR GLUCOSE CONTROL SOLUTIONK090389AP-1000 BLOOD GLUCOSE MONITORING SYSTEM

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.

K260545CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System; CONTOUR® NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes CareK262116TRUE 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.

Official Source

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