Cleared Traditional

INRATIO/INRATIO2 TEST STRIPS

K092987 · Biosite Incorporated · Hematology
Jun 2010
Decision
256d
Days
Class 2
Risk

About This 510(k) Submission

K092987 is an FDA 510(k) clearance for the INRATIO/INRATIO2 TEST STRIPS, a Test, Time, Prothrombin (Class II — Special Controls, product code GJS), submitted by Biosite Incorporated (San Deigo, US). The FDA issued a Cleared decision on June 11, 2010, 256 days after receiving the submission on September 28, 2009. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7750.

Submission Details

510(k) Number K092987 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 2009
Decision Date June 11, 2010
Days to Decision 256 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GJS — Test, Time, Prothrombin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7750