FDA 510(k)

PRECISION XCEED DIABETES MONITORING SYSTEM

K-Number: K033845 · 2004-01-08

Decision Date2004-01-08

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

PRECISION XCEED DIABETES MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 2004-01-08 under 510(k) number K033845. 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 PRECISION XCEED DIABETES MONITORING SYSTEM?

PRECISION XCEED DIABETES MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2004-01-08. The listed applicant is Abbott Laboratories. The 510(k) number is K033845.

When did PRECISION XCEED DIABETES MONITORING SYSTEM receive FDA 510(k) clearance?

PRECISION XCEED DIABETES MONITORING SYSTEM received FDA 510(k) clearance on 2004-01-08, under 510(k) number K033845.

Who is the listed applicant for PRECISION XCEED DIABETES MONITORING SYSTEM?

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

What is the FDA product code for PRECISION XCEED DIABETES MONITORING SYSTEM?

The FDA product code for PRECISION XCEED DIABETES MONITORING SYSTEM is NBW. This falls under the OB/GYN category.

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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.