Cleared Traditional

K912888 - URITEC TEST STRIP & HUMAN URINE + & - TEST CONTROL

K912888 · Dynagen, Inc. · Toxicology device
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Feb 1992
Decision
238d
Days
-
Risk

K912888 is an FDA 510(k) clearance for the URITEC TEST STRIP & HUMAN URINE + & - TEST CONTROL. Classified as Strip, Test Isoniazid (product code MIG).

Submitted by Dynagen, Inc. (Cambridge, US). The FDA issued a Cleared decision on February 24, 1992 after a review of 238 days - an extended review cycle.

This device falls under the Toxicology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

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FDA 510(k) Submission Details - K912888

510(k) Number K912888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1991
Decision Date February 24, 1992
Days to Decision 238 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
151d slower than avg
Panel avg: 87d · This submission: 238d
Pathway characteristics
Predicate-based equivalence.

MIG Device Classification - Class 0,

Product Code MIG Strip, Test Isoniazid
Device Class -