Cleared Traditional

AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHED

K021162 · Sigma Diagnostics, Inc. · Hematology
Aug 2002
Decision
141d
Days
Class 2
Risk

About This 510(k) Submission

K021162 is an FDA 510(k) clearance for the AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHED, a System, Multipurpose For In Vitro Coagulation Studies (Class II — Special Controls, product code JPA), submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on August 30, 2002, 141 days after receiving the submission on April 11, 2002. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K021162 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 2002
Decision Date August 30, 2002
Days to Decision 141 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

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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