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FDA 510(k)

TEMAFLOXCIN, 5MCG, SENSI DISC

K-Number: K920787 · 1992-04-08

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1992-04-08
Product CodeJTN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

TEMAFLOXCIN, 5MCG, SENSI DISC is the device name listed in this FDA 510(k) record. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. It received FDA 510(k) clearance on 1992-04-08 under 510(k) number K920787. 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 TEMAFLOXCIN, 5MCG, SENSI DISC?

TEMAFLOXCIN, 5MCG, SENSI DISC is a medical device that received FDA 510(k) clearance on 1992-04-08. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K920787.

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

TEMAFLOXCIN, 5MCG, SENSI DISC received FDA 510(k) clearance on 1992-04-08, under 510(k) number K920787.

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

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

What is the FDA product code for TEMAFLOXCIN, 5MCG, SENSI DISC?

The FDA product code for TEMAFLOXCIN, 5MCG, 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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