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FDA 510(k)

TransFix/EDTA Vacuum Blood Collection Tubes

K-Number: K162723 · 2017-06-22

ApplicantCaltag Medsystems, Ltd.
Decision Date2017-06-22
Product CodeGIM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TransFix/EDTA Vacuum Blood Collection Tubes is a medical device manufactured by Caltag Medsystems, Ltd.. It received FDA 510(k) clearance on 2017-06-22 under approval number K162723. The device is classified under product code GIM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TransFix/EDTA Vacuum Blood Collection Tubes?

TransFix/EDTA Vacuum Blood Collection Tubes is a medical device that received FDA 510(k) clearance on 2017-06-22. It is manufactured by Caltag Medsystems, Ltd.. The 510(k) number is K162723.

When was TransFix/EDTA Vacuum Blood Collection Tubes approved by the FDA?

TransFix/EDTA Vacuum Blood Collection Tubes received FDA 510(k) clearance on 2017-06-22, under approval number K162723.

What company makes TransFix/EDTA Vacuum Blood Collection Tubes?

TransFix/EDTA Vacuum Blood Collection Tubes is manufactured by Caltag Medsystems, Ltd..

What is the FDA product code for TransFix/EDTA Vacuum Blood Collection Tubes?

The FDA product code for TransFix/EDTA Vacuum Blood Collection Tubes is GIM.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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