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FDA 510(k)

TROVAFLOXACIN 10G, SENSI-DISC

K-Number: K980683 · 1998-05-01

ApplicantBecton Dickinson Microbiology Systems
Decision Date1998-05-01
Product CodeJTN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

TROVAFLOXACIN 10G, SENSI-DISC 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 1998-05-01 under 510(k) number K980683. The device is classified under product code JTN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TROVAFLOXACIN 10G, SENSI-DISC?

TROVAFLOXACIN 10G, SENSI-DISC is a medical device that received FDA 510(k) clearance on 1998-05-01. The listed applicant is Becton Dickinson Microbiology Systems. The 510(k) number is K980683.

When did TROVAFLOXACIN 10G, SENSI-DISC receive FDA 510(k) clearance?

TROVAFLOXACIN 10G, SENSI-DISC received FDA 510(k) clearance on 1998-05-01, under 510(k) number K980683.

Who is the listed applicant for TROVAFLOXACIN 10G, SENSI-DISC?

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 TROVAFLOXACIN 10G, SENSI-DISC?

The FDA product code for TROVAFLOXACIN 10G, SENSI-DISC is JTN.

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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-DISCK974578GREPAFLOXACIN, 5 MG, SENSI-DISCK970333BACTEC MYCO/F LYTIC CULTURE VIALSK970512BACTEC MYCO/F LYTIC CULTURE VIALS

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Related Devices (Code: JTN)

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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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