FDA 510(k)

BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes

Numéro K : K213670 · 2023-08-25

Date de décision2023-08-25

Code produitGIM

Comité consultatifCH

DécisionSubstantially Equivalent

Résumé du dispositif

BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes is the device name listed in this FDA 510(k) record. The listed applicant is Becton, Dickinson and Company. It received FDA 510(k) clearance on 2023-08-25 under 510(k) number K213670. The device is classified under product code GIM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes?

BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes is a medical device that received FDA 510(k) clearance on 2023-08-25. The listed applicant is Becton, Dickinson and Company. The 510(k) number is K213670.

When did BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes receive FDA 510(k) clearance?

BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes received FDA 510(k) clearance on 2023-08-25, under 510(k) number K213670.

Who is the listed applicant for BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes?

The FDA 510(k) record lists Becton, Dickinson and Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes?

The FDA product code for BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes is GIM.

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Source officielle

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