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FDA 510(k)

VACUETTE® QUICKSHIELD Complete (Plus)

K-Number: K233979 · 2024-07-19

ApplicantGreiner Bio-One North America, Inc.
Decision Date2024-07-19
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VACUETTE® QUICKSHIELD Complete (Plus) is the device name listed in this FDA 510(k) record. The listed applicant is Greiner Bio-One North America, Inc.. It received FDA 510(k) clearance on 2024-07-19 under 510(k) number K233979. 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 VACUETTE® QUICKSHIELD Complete (Plus)?

VACUETTE® QUICKSHIELD Complete (Plus) is a medical device that received FDA 510(k) clearance on 2024-07-19. The listed applicant is Greiner Bio-One North America, Inc.. The 510(k) number is K233979.

When did VACUETTE® QUICKSHIELD Complete (Plus) receive FDA 510(k) clearance?

VACUETTE® QUICKSHIELD Complete (Plus) received FDA 510(k) clearance on 2024-07-19, under 510(k) number K233979.

Who is the listed applicant for VACUETTE® QUICKSHIELD Complete (Plus)?

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

What is the FDA product code for VACUETTE® QUICKSHIELD Complete (Plus)?

The FDA product code for VACUETTE® QUICKSHIELD Complete (Plus) is JKA.

Related Devices (Code: JKA)

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.

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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.

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