Loracarbef 30MCG, Sensi Disc

FDA 510(k) K920786 · Bd Becton Dickinson Vacutainer Systems Preanalytic

Substantially Equivalent

510(k) numberK920786

Submission

Device name
Loracarbef 30MCG, Sensi Disc
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
Cockeysville, MD, US
Received
February 20, 1992
Decision date
April 8, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
JTN – Susceptibility Test Discs, Antimicrobial
Device class
Class II (moderate risk)
Regulation
21 CFR 866.1620
Specialty
Microbiology

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Questions and answers

When was Loracarbef 30MCG, Sensi Disc cleared by the FDA?

Loracarbef 30MCG, Sensi Disc (K920786) received a 510(k) decision of Substantially Equivalent on April 8, 1992, 48 days after the submission was received.

What is the product code of K920786?

The FDA product code is JTN – Susceptibility Test Discs, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 866.1620.