FDA 510(k)

BD Phoenix Automated Microbiology System-Ertapenem 0.0625-8 mcg/ml

K-Nummer: K151320 · 2016-01-15

AntragstellerBecton, Dickinson and Company

Entscheidungsdatum2016-01-15

ProduktcodeLON

BeratungsausschussMI

EntscheidungSubstantially Equivalent

Produktübersicht

BD Phoenix Automated Microbiology System-Ertapenem 0.0625-8 mcg/ml 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 2016-01-15 under 510(k) number K151320. The device is classified under product code LON. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the BD Phoenix Automated Microbiology System-Ertapenem 0.0625-8 mcg/ml?

BD Phoenix Automated Microbiology System-Ertapenem 0.0625-8 mcg/ml is a medical device that received FDA 510(k) clearance on 2016-01-15. The listed applicant is Becton, Dickinson and Company. The 510(k) number is K151320.

When did BD Phoenix Automated Microbiology System-Ertapenem 0.0625-8 mcg/ml receive FDA 510(k) clearance?

BD Phoenix Automated Microbiology System-Ertapenem 0.0625-8 mcg/ml received FDA 510(k) clearance on 2016-01-15, under 510(k) number K151320.

Who is the listed applicant for BD Phoenix Automated Microbiology System-Ertapenem 0.0625-8 mcg/ml?

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 Phoenix Automated Microbiology System-Ertapenem 0.0625-8 mcg/ml?

The FDA product code for BD Phoenix Automated Microbiology System-Ertapenem 0.0625-8 mcg/ml is LON.

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K262163BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hinton Broth K260128BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes K252506BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached Holder K252378BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection Tube K260184Onclarity™ Self-Collection Kit K252040BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection Tubes

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Verwandte Geräte (Code: LON)

K260282VITEK 2 AST-Streptococcus Inducible Clindamycin ResistancebioMerieux, Inc.K260281VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)BIOMERIEUX K251579VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)bioMerieux, Inc.K251713BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL)Becton, Dickinson and Company K250447BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL)Becton, Dickinson and Company K234012VITEK COMPACT PRObioMerieux, Inc.

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