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FDA 510(k)

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

K-Number: K161329 · 2016-12-02

ApplicantChrono-Log Corp.
Decision Date2016-12-02
Product CodeJOZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channel is a medical device manufactured by Chrono-Log Corp.. It received FDA 510(k) clearance on 2016-12-02 under approval number K161329. The device is classified under product code JOZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channel?

Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channel is a medical device that received FDA 510(k) clearance on 2016-12-02. It is manufactured by Chrono-Log Corp.. The 510(k) number is K161329.

When was Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channel approved by the FDA?

Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channel received FDA 510(k) clearance on 2016-12-02, under approval number K161329.

What company makes Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channel?

Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channel is manufactured by Chrono-Log Corp..

What is the FDA product code for Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channel?

The FDA product code for Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channel is JOZ.

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Official Source

View on FDA Database →

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