Cleared Traditional

K962615 - TUMORLOCALIZER MRI (FDA 510(k) Clearance)

K962615 · Ferguson Medical · Toxicology device
Mar 1998
Decision
624d
Days
—
Risk

K962615 is an FDA 510(k) clearance for the TUMORLOCALIZER MRI. This device is classified as a Strip, Test Isoniazid.

Submitted by Ferguson Medical (Chico, US). The FDA issued a Cleared decision on March 19, 1998, 624 days after receiving the submission on July 3, 1996.

This device falls under the Toxicology FDA review panel.

Submission Details

510(k) Number K962615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1996
Decision Date March 19, 1998
Days to Decision 624 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code MIG — Strip, Test Isoniazid
Device Class —