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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 the device name listed in this FDA 510(k) record. The listed applicant is Caltag Medsystems, Ltd.. It received FDA 510(k) clearance on 2017-06-22 under 510(k) 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. The listed applicant is Caltag Medsystems, Ltd.. The 510(k) number is K162723.

When did TransFix/EDTA Vacuum Blood Collection Tubes receive FDA 510(k) clearance?

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

Who is the listed applicant for TransFix/EDTA Vacuum Blood Collection Tubes?

The FDA 510(k) record lists Caltag Medsystems, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Related Devices (Code: GIM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240455BD Vacutainer® Citrate Blood Collection TubesBecton, Dickinson and CompanyK230493BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection TubeBecton, Dickinson and CompanyK213670BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection TubesBecton, Dickinson and Company

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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