FDA 510(k)

MiniCollect K2E K2EDTA Tubes

K-Number: K182078 · 2019-01-25

Decision Date2019-01-25

Product CodeJKA

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

MiniCollect K2E K2EDTA Tubes is a medical device manufactured by Greiner Bio-One Na, Inc.. It received FDA 510(k) clearance on 2019-01-25 under approval number K182078. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MiniCollect K2E K2EDTA Tubes?

MiniCollect K2E K2EDTA Tubes is a medical device that received FDA 510(k) clearance on 2019-01-25. It is manufactured by Greiner Bio-One Na, Inc.. The 510(k) number is K182078.

When was MiniCollect K2E K2EDTA Tubes approved by the FDA?

MiniCollect K2E K2EDTA Tubes received FDA 510(k) clearance on 2019-01-25, under approval number K182078.

What company makes MiniCollect K2E K2EDTA Tubes?

MiniCollect K2E K2EDTA Tubes is manufactured by Greiner Bio-One Na, Inc..

What is the FDA product code for MiniCollect K2E K2EDTA Tubes?

The FDA product code for MiniCollect K2E K2EDTA Tubes is JKA.

Other Devices by Greiner Bio-One Na, Inc.

K160532Greiner Holdex K163436Greiner Vacuette Urine Count and Culture, Mannitol tube K180545VACUETTE SAFELINK Holder with male luer lock K173757VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set

Related Devices (Code: JKA)

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Official Source

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