FDA 510(k)

BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial

Numéro K : K161810 · 2017-02-09

Date de décision2017-02-09

Code produitMDB

Comité consultatifMI

DécisionSubstantially Equivalent

Résumé du dispositif

BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial is the device name listed in this FDA 510(k) record. The listed applicant is Becton Dickinson. It received FDA 510(k) clearance on 2017-02-09 under 510(k) number K161810. The device is classified under product code MDB. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial?

BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial is a medical device that received FDA 510(k) clearance on 2017-02-09. The listed applicant is Becton Dickinson. The 510(k) number is K161810.

When did BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial receive FDA 510(k) clearance?

BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial received FDA 510(k) clearance on 2017-02-09, under 510(k) number K161810.

Who is the listed applicant for BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial?

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

What is the FDA product code for BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial?

The FDA product code for BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial is MDB.

Essais cliniques associés

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Autres dossiers indiquant Becton Dickinson en tant que demandeur

K243062BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229); BD Intelliport Gateway (516232); BD Intelliport Mount (516233); BD Intelliport Charger (516231)K161306BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial

Dispositifs connexes (Code : MDB)

K260213BD BACTEC FXI Culture SystemBD Diagnostic Systems K222591BD BACTEC™ Plus Aerobic/F Culture VialsBecton, Dickinson and Company K222559BD BACTEC™ Myco/F Lytic Culture VialsBecton, Dickinson and Company K190405BACT/ALERT MP Reagent SystembioMerieux, Inc.K183166BacT/ALERT FA Plus; BacT/ALERT PF PlusbioMerieux, Inc.K173873BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic VialBecton, Dickinson and Company

Source officielle

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