Cleared Traditional

CHRONO-LOG WHOLE BLOOD AGGREGOMETER, MODELS 591A AND 592A

K032951 · Chrono-Log Corp. · Hematology
Apr 2004
Decision
193d
Days
Class 2
Risk

About This 510(k) Submission

K032951 is an FDA 510(k) clearance for the CHRONO-LOG WHOLE BLOOD AGGREGOMETER, MODELS 591A AND 592A, a System, Automated Platelet Aggregation (Class II — Special Controls, product code JOZ), submitted by Chrono-Log Corp. (Havertown, US). The FDA issued a Cleared decision on April 2, 2004, 193 days after receiving the submission on September 22, 2003. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5700.

Submission Details

510(k) Number K032951 FDA.gov
FDA Decision Cleared SESE
Date Received September 22, 2003
Decision Date April 02, 2004
Days to Decision 193 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code JOZ — System, Automated Platelet Aggregation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5700

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