Gemifloxacin, 5UG BBL Sensi-Disc
FDA 510(k) K050062 · Becton, Dickinson & CO
510(k) numberK050062
Submission
- Device name
- Gemifloxacin, 5UG BBL Sensi-Disc
- Applicant
- Becton, Dickinson & CO
Sparks, MD, US - Received
- January 11, 2005
- Decision date
- February 10, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 Gemifloxacin, 5UG BBL Sensi-Disc cleared by the FDA?
Gemifloxacin, 5UG BBL Sensi-Disc (K050062) received a 510(k) decision of Substantially Equivalent on February 10, 2005, 30 days after the submission was received.
What is the product code of K050062?
The FDA product code is JTN – Susceptibility Test Discs, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 866.1620.