Cleared Traditional

HEMORAM/AGGRAM ANALYZER

K050053 · Helena Laboratories · Hematology
Jul 2005
Decision
182d
Days
Class 2
Risk

About This 510(k) Submission

K050053 is an FDA 510(k) clearance for the HEMORAM/AGGRAM ANALYZER, a System, Multipurpose For In Vitro Coagulation Studies (Class II — Special Controls, product code JPA), submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on July 11, 2005, 182 days after receiving the submission on January 10, 2005. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K050053 FDA.gov
FDA Decision Cleared SESE
Date Received January 10, 2005
Decision Date July 11, 2005
Days to Decision 182 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

Device Classification

Product Code JPA — System, Multipurpose For In Vitro Coagulation Studies
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5425

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