Cefprozil 30MCG, Sensi Disc

FDA 510(k) K920473 · Bd Becton Dickinson Vacutainer Systems Preanalytic

Substantially Equivalent

510(k) numberK920473

Submission

Device name
Cefprozil 30MCG, Sensi Disc
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
Cockeysville, MD, US
Received
January 28, 1992
Decision date
March 23, 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 Cefprozil 30MCG, Sensi Disc cleared by the FDA?

Cefprozil 30MCG, Sensi Disc (K920473) received a 510(k) decision of Substantially Equivalent on March 23, 1992, 55 days after the submission was received.

What is the product code of K920473?

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