FDA 510(k)

AP-1000 BLOOD GLUCOSE MONITORING SYSTEM

K-Number: K090389 · 2009-07-14

Decision Date2009-07-14

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

AP-1000 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 2009-07-14 under 510(k) number K090389. 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 AP-1000 BLOOD GLUCOSE MONITORING SYSTEM?

AP-1000 BLOOD GLUCOSE MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2009-07-14. The listed applicant is Bestgen Biotech Corp.. The 510(k) number is K090389.

When did AP-1000 BLOOD GLUCOSE MONITORING SYSTEM receive FDA 510(k) clearance?

AP-1000 BLOOD GLUCOSE MONITORING SYSTEM received FDA 510(k) clearance on 2009-07-14, under 510(k) number K090389.

Who is the listed applicant for AP-1000 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 AP-1000 BLOOD GLUCOSE MONITORING SYSTEM?

The FDA product code for AP-1000 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

K103230AP-3000 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION K103116AP-2000, AP-2010, AND AP-2020 BLOOD GLUCOSE MONITORING SYSTEM K103044AP-1010 AND AP-1020 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION K100437AP-1000 BLOOD GLUCOSE MONITORING SYSTEM, MODEL AP-1000, MAJOR GLUCOSE CONTROL SOLUTION K072274MAJOR III BLOOD GLUCOSE MONITORING SYSTEM

Related Devices (Code: NBW)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.