Cleared Traditional

K912888 - URITEC TEST STRIP & HUMAN URINE + & - TEST CONTROL (FDA 510(k) Clearance)

K912888 · Dynagen, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Dynagen, Inc. devices

Submission Details

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.

Device Classification

Product Code MIG Strip, Test Isoniazid
Device Class -