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FDA 510(k)

SPARFLOZACIN, 5 MCG, SENSI-DISC

K-Number: K970385 · 1997-03-10

ApplicantBecton Dickinson Microbiology Systems
Decision Date1997-03-10
Product CodeJTN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SPARFLOZACIN, 5 MCG, 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 1997-03-10 under 510(k) number K970385. 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 SPARFLOZACIN, 5 MCG, SENSI-DISC?

SPARFLOZACIN, 5 MCG, SENSI-DISC is a medical device that received FDA 510(k) clearance on 1997-03-10. The listed applicant is Becton Dickinson Microbiology Systems. The 510(k) number is K970385.

When did SPARFLOZACIN, 5 MCG, SENSI-DISC receive FDA 510(k) clearance?

SPARFLOZACIN, 5 MCG, SENSI-DISC received FDA 510(k) clearance on 1997-03-10, under 510(k) number K970385.

Who is the listed applicant for SPARFLOZACIN, 5 MCG, 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 SPARFLOZACIN, 5 MCG, SENSI-DISC?

The FDA product code for SPARFLOZACIN, 5 MCG, SENSI-DISC is JTN.

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Other records listing Becton Dickinson Microbiology Systems as applicant

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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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