Cleared Traditional

HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED), BIOPHEN ACT. PC-R CONTROL PLASMA AND BIOPHEN

K083729 · Aniara Diagnostica, LLC · Hematology
May 2009
Decision
143d
Days
Class 2
Risk

About This 510(k) Submission

K083729 is an FDA 510(k) clearance for the HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED), BIOPHEN ACT. PC-R CONTROL PLASMA AND BIOPHEN, a Test, Time, Partial Thromboplastin (Class II — Special Controls, product code GGW), submitted by Aniara Diagnostica, LLC (Mason, US). The FDA issued a Cleared decision on May 8, 2009, 143 days after receiving the submission on December 16, 2008. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7925.

Submission Details

510(k) Number K083729 FDA.gov
FDA Decision Cleared SESE
Date Received December 16, 2008
Decision Date May 08, 2009
Days to Decision 143 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GGW — Test, Time, Partial Thromboplastin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7925