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FDA 510(k)

GENTAMICIN 120 UG, STREPTOMYCIN 30 UG SENSI-DISC SUSPECTIBILITY TESTS

K-Number: K943407 · 1994-10-27

ApplicantBecton Dickinson Microbiology Systems
Decision Date1994-10-27
Product CodeJTN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

GENTAMICIN 120 UG, STREPTOMYCIN 30 UG SENSI-DISC SUSPECTIBILITY TESTS 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 1994-10-27 under 510(k) number K943407. 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 GENTAMICIN 120 UG, STREPTOMYCIN 30 UG SENSI-DISC SUSPECTIBILITY TESTS?

GENTAMICIN 120 UG, STREPTOMYCIN 30 UG SENSI-DISC SUSPECTIBILITY TESTS is a medical device that received FDA 510(k) clearance on 1994-10-27. The listed applicant is Becton Dickinson Microbiology Systems. The 510(k) number is K943407.

When did GENTAMICIN 120 UG, STREPTOMYCIN 30 UG SENSI-DISC SUSPECTIBILITY TESTS receive FDA 510(k) clearance?

GENTAMICIN 120 UG, STREPTOMYCIN 30 UG SENSI-DISC SUSPECTIBILITY TESTS received FDA 510(k) clearance on 1994-10-27, under 510(k) number K943407.

Who is the listed applicant for GENTAMICIN 120 UG, STREPTOMYCIN 30 UG SENSI-DISC SUSPECTIBILITY TESTS?

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 GENTAMICIN 120 UG, STREPTOMYCIN 30 UG SENSI-DISC SUSPECTIBILITY TESTS?

The FDA product code for GENTAMICIN 120 UG, STREPTOMYCIN 30 UG SENSI-DISC SUSPECTIBILITY TESTS 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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