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FDA 510(k)

URITEC TEST STRIP & HUMAN URINE + & - TEST CONTROL

K-Number: K912888 · 1992-02-24

ApplicantDynagen, Inc.
Decision Date1992-02-24
Product CodeMIG
DecisionSubstantially Equivalent

Device Summary

URITEC TEST STRIP & HUMAN URINE + & - TEST CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Dynagen, Inc.. It received FDA 510(k) clearance on 1992-02-24 under 510(k) number K912888. The device is classified under product code MIG. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URITEC TEST STRIP & HUMAN URINE + & - TEST CONTROL?

URITEC TEST STRIP & HUMAN URINE + & - TEST CONTROL is a medical device that received FDA 510(k) clearance on 1992-02-24. The listed applicant is Dynagen, Inc.. The 510(k) number is K912888.

When did URITEC TEST STRIP & HUMAN URINE + & - TEST CONTROL receive FDA 510(k) clearance?

URITEC TEST STRIP & HUMAN URINE + & - TEST CONTROL received FDA 510(k) clearance on 1992-02-24, under 510(k) number K912888.

Who is the listed applicant for URITEC TEST STRIP & HUMAN URINE + & - TEST CONTROL?

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

What is the FDA product code for URITEC TEST STRIP & HUMAN URINE + & - TEST CONTROL?

The FDA product code for URITEC TEST STRIP & HUMAN URINE + & - TEST CONTROL is MIG.

Related Clinical Trials

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Other records listing Dynagen, Inc. 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.

K963733NICCHECK IK943051MYCOAKT M. TUBERCULOSIS CUULTURE ID KITK943050MYCOAKT M KANSASII CULTURE ID KITK943049MYCOAKT M. AVIUM CULTURE ID KITK931105PROCHECK(TM) BLIND PERFORMANCE SPECIMENS

Related Devices (Code: MIG)

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.

K962615TUMORLOCALIZER MRIFerguson Medical

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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