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 the device name listed in this FDA 510(k) record. The listed applicant is Greiner Bio-One Na, Inc.. It received FDA 510(k) clearance on 2019-01-25 under 510(k) 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. The listed applicant is Greiner Bio-One Na, Inc.. The 510(k) number is K182078.

When did MiniCollect K2E K2EDTA Tubes receive FDA 510(k) clearance?

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

Who is the listed applicant for MiniCollect K2E K2EDTA Tubes?

The FDA 510(k) record lists Greiner Bio-One Na, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Greiner Bio-One Na, Inc. as applicant

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.

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

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.