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FDA 510(k)

BACTEC(R) 9000TB SYSTEM

K-Number: K946268 · 1996-05-21

ApplicantBecton Dickinson Diagnostic Instrument Systems
Decision Date1996-05-21
Product CodeMDB
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BACTEC(R) 9000TB SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Becton Dickinson Diagnostic Instrument Systems. It received FDA 510(k) clearance on 1996-05-21 under 510(k) number K946268. 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 BACTEC(R) 9000TB SYSTEM?

BACTEC(R) 9000TB SYSTEM is a medical device that received FDA 510(k) clearance on 1996-05-21. The listed applicant is Becton Dickinson Diagnostic Instrument Systems. The 510(k) number is K946268.

When did BACTEC(R) 9000TB SYSTEM receive FDA 510(k) clearance?

BACTEC(R) 9000TB SYSTEM received FDA 510(k) clearance on 1996-05-21, under 510(k) number K946268.

Who is the listed applicant for BACTEC(R) 9000TB SYSTEM?

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

What is the FDA product code for BACTEC(R) 9000TB SYSTEM?

The FDA product code for BACTEC(R) 9000TB SYSTEM is MDB.

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Other records listing Becton Dickinson Diagnostic Instrument Systems 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.

K954923BACTEC FUNGAL MEDIUMK954932BBL MGIT PRODUCTSK962210BACTEC 9050 SYSTEMK960827QBC ACCUTUBE(423406)/QBC AUTOREAD(424571)K954930BACTEC CULTURE VIALS, LYTIC, ANAEROBICK954921BACTEC STANDARD/10 AEROBIC/F CULTURE VIALS

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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 SystemsK222559BD BACTEC™ Myco/F Lytic Culture VialsBecton, Dickinson and CompanyK222591BD BACTEC™ Plus Aerobic/F 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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