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FDA 510(k)

DIACHECK BLOOD GLUCOSE MONITORING SYSTEM MODEL: PREMIUM

K-Number: K100806 · 2011-09-16

ApplicantDelbio Incorporation
Decision Date2011-09-16
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIACHECK BLOOD GLUCOSE MONITORING SYSTEM MODEL: PREMIUM is the device name listed in this FDA 510(k) record. The listed applicant is Delbio Incorporation. It received FDA 510(k) clearance on 2011-09-16 under 510(k) number K100806. 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 DIACHECK BLOOD GLUCOSE MONITORING SYSTEM MODEL: PREMIUM?

DIACHECK BLOOD GLUCOSE MONITORING SYSTEM MODEL: PREMIUM is a medical device that received FDA 510(k) clearance on 2011-09-16. The listed applicant is Delbio Incorporation. The 510(k) number is K100806.

When did DIACHECK BLOOD GLUCOSE MONITORING SYSTEM MODEL: PREMIUM receive FDA 510(k) clearance?

DIACHECK BLOOD GLUCOSE MONITORING SYSTEM MODEL: PREMIUM received FDA 510(k) clearance on 2011-09-16, under 510(k) number K100806.

Who is the listed applicant for DIACHECK BLOOD GLUCOSE MONITORING SYSTEM MODEL: PREMIUM?

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

What is the FDA product code for DIACHECK BLOOD GLUCOSE MONITORING SYSTEM MODEL: PREMIUM?

The FDA product code for DIACHECK BLOOD GLUCOSE MONITORING SYSTEM MODEL: PREMIUM is NBW. This falls under the OB/GYN category.

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Other records listing Delbio Incorporation 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.

K132338DA01 BLOOD GLUCOSE MONITORING SYSTEMK130244DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEMK120866DA01 BLOOD GLUCOSE MONITORING SYSTEMK103329DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM; DIATRUE PLUS BLOOD GLUCOSE TEST STRIP; DIATRUE GLUCOSE CONTROL SOLUTIONK113343DIACHECK SMART/SUPERIOR 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.

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Official Source

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