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FDA 510(k)

CEFOTAXIME/CLAVULANIC, 30/10UG, BBL SENSI-DISC AND CEFTAZIDIME/CLAVULANIC ACID, 30/10UG, BBL SENSI-DISC

K-Number: K993577 · 1999-12-01

ApplicantBecton Dickinson Microbiology Systems
Decision Date1999-12-01
Product CodeJTN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CEFOTAXIME/CLAVULANIC, 30/10UG, BBL SENSI-DISC AND CEFTAZIDIME/CLAVULANIC ACID, 30/10UG, BBL 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 1999-12-01 under 510(k) number K993577. 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 CEFOTAXIME/CLAVULANIC, 30/10UG, BBL SENSI-DISC AND CEFTAZIDIME/CLAVULANIC ACID, 30/10UG, BBL SENSI-DISC?

CEFOTAXIME/CLAVULANIC, 30/10UG, BBL SENSI-DISC AND CEFTAZIDIME/CLAVULANIC ACID, 30/10UG, BBL SENSI-DISC is a medical device that received FDA 510(k) clearance on 1999-12-01. The listed applicant is Becton Dickinson Microbiology Systems. The 510(k) number is K993577.

When did CEFOTAXIME/CLAVULANIC, 30/10UG, BBL SENSI-DISC AND CEFTAZIDIME/CLAVULANIC ACID, 30/10UG, BBL SENSI-DISC receive FDA 510(k) clearance?

CEFOTAXIME/CLAVULANIC, 30/10UG, BBL SENSI-DISC AND CEFTAZIDIME/CLAVULANIC ACID, 30/10UG, BBL SENSI-DISC received FDA 510(k) clearance on 1999-12-01, under 510(k) number K993577.

Who is the listed applicant for CEFOTAXIME/CLAVULANIC, 30/10UG, BBL SENSI-DISC AND CEFTAZIDIME/CLAVULANIC ACID, 30/10UG, BBL 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 CEFOTAXIME/CLAVULANIC, 30/10UG, BBL SENSI-DISC AND CEFTAZIDIME/CLAVULANIC ACID, 30/10UG, BBL SENSI-DISC?

The FDA product code for CEFOTAXIME/CLAVULANIC, 30/10UG, BBL SENSI-DISC AND CEFTAZIDIME/CLAVULANIC ACID, 30/10UG, BBL SENSI-DISC is 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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