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FDA 510(k)

Greiner Vacuette Urine Count and Culture, Mannitol tube

K-Number: K163436 · 2017-03-06

ApplicantGreiner Bio-One Na, Inc.
Decision Date2017-03-06
Product CodeJSM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Greiner Vacuette Urine Count and Culture, Mannitol tube is a medical device manufactured by Greiner Bio-One Na, Inc.. It received FDA 510(k) clearance on 2017-03-06 under approval number K163436. The device is classified under product code JSM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Greiner Vacuette Urine Count and Culture, Mannitol tube?

Greiner Vacuette Urine Count and Culture, Mannitol tube is a medical device that received FDA 510(k) clearance on 2017-03-06. It is manufactured by Greiner Bio-One Na, Inc.. The 510(k) number is K163436.

When was Greiner Vacuette Urine Count and Culture, Mannitol tube approved by the FDA?

Greiner Vacuette Urine Count and Culture, Mannitol tube received FDA 510(k) clearance on 2017-03-06, under approval number K163436.

What company makes Greiner Vacuette Urine Count and Culture, Mannitol tube?

Greiner Vacuette Urine Count and Culture, Mannitol tube is manufactured by Greiner Bio-One Na, Inc..

What is the FDA product code for Greiner Vacuette Urine Count and Culture, Mannitol tube?

The FDA product code for Greiner Vacuette Urine Count and Culture, Mannitol tube is JSM.

Related Clinical Trials

NCT06976125 Application of a Prediction Model for Directing Antibiotic Use in the Treatment of Urinary Tract Infection in an Ambulatory Setting RECRUITING

Other Devices by Greiner Bio-One Na, Inc.

K160532Greiner Holdex K180545VACUETTE SAFELINK Holder with male luer lock K173757VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set K182078MiniCollect K2E K2EDTA Tubes

Related Devices (Code: JSM)

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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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