Cleared Traditional

CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 700

K050265 · Chrono-Log Corp. · Hematology
Oct 2005
Decision
252d
Days
Class 2
Risk

About This 510(k) Submission

K050265 is an FDA 510(k) clearance for the CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 700, 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 October 14, 2005, 252 days after receiving the submission on February 4, 2005. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5700.

Submission Details

510(k) Number K050265 FDA.gov
FDA Decision Cleared SESE
Date Received February 04, 2005
Decision Date October 14, 2005
Days to Decision 252 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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