Cleared Traditional

K024080 - SECQUIRE CELL SEPARATOR
(FDA 510(k) Clearance)

K024080 · Perfusion Partners & Assoc., Inc. · Hematology
Jul 2003
Decision
204d
Days
Class 1
Risk

K024080 is an FDA 510(k) clearance for the SECQUIRE CELL SEPARATOR, a Centrifuges (micro, Ultra, Refrigerated) For Clinical Use (Class I — General Controls, product code JQC), submitted by Perfusion Partners & Assoc., Inc. (Crofton, US). The FDA issued a Cleared decision on July 2, 2003, 204 days after receiving the submission on December 10, 2002. This device falls under the Hematology review panel. Regulated under 21 CFR 862.2050.

Submission Details

510(k) Number K024080 FDA.gov
FDA Decision Cleared SESE
Date Received December 10, 2002
Decision Date July 02, 2003
Days to Decision 204 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

Device Classification

Product Code JQC — Centrifuges (micro, Ultra, Refrigerated) For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2050

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