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FDA 510(k)

STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL SOLUTIONS

K-Number: K030650 · 2003-04-14

ApplicantUridynamics, Inc.
Decision Date2003-04-14
Product CodeCEN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL SOLUTIONS is the device name listed in this FDA 510(k) record. The listed applicant is Uridynamics, Inc.. It received FDA 510(k) clearance on 2003-04-14 under 510(k) number K030650. The device is classified under product code CEN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL SOLUTIONS?

STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL SOLUTIONS is a medical device that received FDA 510(k) clearance on 2003-04-14. The listed applicant is Uridynamics, Inc.. The 510(k) number is K030650.

When did STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL SOLUTIONS receive FDA 510(k) clearance?

STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL SOLUTIONS received FDA 510(k) clearance on 2003-04-14, under 510(k) number K030650.

Who is the listed applicant for STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL SOLUTIONS?

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

What is the FDA product code for STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL SOLUTIONS?

The FDA product code for STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL SOLUTIONS is CEN.

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Related Devices (Code: CEN)

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

View on FDA Database →

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

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