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FDA 510(k)

BACTEC MYCO/F-SPUTA CULTURE VIALS

K-Number: K972758 · 1997-08-08

ApplicantBecton Dickinson Microbiology Systems
Decision Date1997-08-08
Product CodeMDB
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BACTEC MYCO/F-SPUTA CULTURE VIALS is the device name listed in this FDA 510(k) record. The listed applicant is Becton Dickinson Microbiology Systems. It received FDA 510(k) clearance on 1997-08-08 under 510(k) number K972758. 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 MYCO/F-SPUTA CULTURE VIALS?

BACTEC MYCO/F-SPUTA CULTURE VIALS is a medical device that received FDA 510(k) clearance on 1997-08-08. The listed applicant is Becton Dickinson Microbiology Systems. The 510(k) number is K972758.

When did BACTEC MYCO/F-SPUTA CULTURE VIALS receive FDA 510(k) clearance?

BACTEC MYCO/F-SPUTA CULTURE VIALS received FDA 510(k) clearance on 1997-08-08, under 510(k) number K972758.

Who is the listed applicant for BACTEC MYCO/F-SPUTA CULTURE VIALS?

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

What is the FDA product code for BACTEC MYCO/F-SPUTA CULTURE VIALS?

The FDA product code for BACTEC MYCO/F-SPUTA CULTURE VIALS is MDB.

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Other records listing Becton Dickinson Microbiology 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.

K993577CEFOTAXIME/CLAVULANIC, 30/10UG, BBL SENSI-DISC AND CEFTAZIDIME/CLAVULANIC ACID, 30/10UG, BBL SENSI-DISCK984631BDPROBETEC ET CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE AMPLIFIED DNA ASSAYK981517CEFDINIR, 5 UG, SENSI-DISCK980683TROVAFLOXACIN 10G, SENSI-DISCK974578GREPAFLOXACIN, 5 MG, SENSI-DISCK970333BACTEC MYCO/F LYTIC CULTURE VIALS

View all 33 devices →

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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