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FDA 510(k)

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

K-Number: K161306 · 2016-08-08

ApplicantBecton Dickinson
Decision Date2016-08-08
Product CodeMDB
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BD BACTEC Standard Anaerobic/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 2016-08-08 under 510(k) number K161306. The device is classified under product code MDB. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial is a medical device that received FDA 510(k) clearance on 2016-08-08. The listed applicant is Becton Dickinson. The 510(k) number is K161306.

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

BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial received FDA 510(k) clearance on 2016-08-08, under 510(k) number K161306.

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

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

Other records listing Becton Dickinson as applicant

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.

K243062BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229); BD Intelliport Gateway (516232); BD Intelliport Mount (516233); BD Intelliport Charger (516231)K170386BD Ultra-Fine™ Insulin Syringe, BD Ultra-Fine™ II Insulin Syringe, BD Insulin Syringes with the BD Ultra-Fine™ needle and BD Insulin Syringes with Micro-Fine™ IV NeedleK163637BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0.25/4- 32/4ug/mL)K161810BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic VialK160164BD Veritor System for Rapid Detection of Flu A + B Labratory KitK160161BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit

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Related Devices (Code: MDB)

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.

K260213BD BACTEC FXI Culture SystemBD Diagnostic SystemsK222591BD BACTEC™ Plus Aerobic/F Culture VialsBecton, Dickinson and CompanyK222559BD BACTEC™ Myco/F Lytic Culture VialsBecton, Dickinson and CompanyK190405BACT/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

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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