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FDA 510(k)

DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM; DIATRUE PLUS BLOOD GLUCOSE TEST STRIP; DIATRUE GLUCOSE CONTROL SOLUTION

K-Number: K103329 · 2012-03-13

ApplicantDelbio Incorporation
Decision Date2012-03-13
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM; DIATRUE PLUS BLOOD GLUCOSE TEST STRIP; DIATRUE GLUCOSE CONTROL SOLUTION is the device name listed in this FDA 510(k) record. The listed applicant is Delbio Incorporation. It received FDA 510(k) clearance on 2012-03-13 under 510(k) number K103329. 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 DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM; DIATRUE PLUS BLOOD GLUCOSE TEST STRIP; DIATRUE GLUCOSE CONTROL SOLUTION?

DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM; DIATRUE PLUS BLOOD GLUCOSE TEST STRIP; DIATRUE GLUCOSE CONTROL SOLUTION is a medical device that received FDA 510(k) clearance on 2012-03-13. The listed applicant is Delbio Incorporation. The 510(k) number is K103329.

When did DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM; DIATRUE PLUS BLOOD GLUCOSE TEST STRIP; DIATRUE GLUCOSE CONTROL SOLUTION receive FDA 510(k) clearance?

DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM; DIATRUE PLUS BLOOD GLUCOSE TEST STRIP; DIATRUE GLUCOSE CONTROL SOLUTION received FDA 510(k) clearance on 2012-03-13, under 510(k) number K103329.

Who is the listed applicant for DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM; DIATRUE PLUS BLOOD GLUCOSE TEST STRIP; DIATRUE GLUCOSE CONTROL SOLUTION?

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 DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM; DIATRUE PLUS BLOOD GLUCOSE TEST STRIP; DIATRUE GLUCOSE CONTROL SOLUTION?

The FDA product code for DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM; DIATRUE PLUS BLOOD GLUCOSE TEST STRIP; DIATRUE GLUCOSE CONTROL SOLUTION is NBW. This falls under the OB/GYN category.

Related Clinical Trials

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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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 SYSTEMK113343DIACHECK SMART/SUPERIOR BLOOD GLUCOSE MONITORING SYSTEMK100806DIACHECK BLOOD GLUCOSE MONITORING SYSTEM MODEL: PREMIUM

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

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