Cleared Special

Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channel

K161329 · Chrono-Log Corp. · Hematology
Dec 2016
Decision
204d
Days
Class 2
Risk

About This 510(k) Submission

K161329 is an FDA 510(k) clearance for the Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channel, 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 December 2, 2016, 204 days after receiving the submission on May 12, 2016. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5700.

Submission Details

510(k) Number K161329 FDA.gov
FDA Decision Cleared SESE
Date Received May 12, 2016
Decision Date December 02, 2016
Days to Decision 204 days
Submission Type Special
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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