Bactec Mgit 960 Sire Kits
FDA 510(k) K014123 · Becton, Dickinson & CO
510(k) numberK014123
Submission
- Device name
- Bactec Mgit 960 Sire Kits
- Applicant
- Becton, Dickinson & CO
Sparks, MD, US - Received
- December 17, 2001
- Decision date
- April 19, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MJA – Susceptibility Test Powders, Antimycobacterial
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.1640
- Specialty
- Microbiology
Other 510(k)s with product code MJA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K052323 | Versatrek Myco Pza KitMJA · Traditional | Trek Diagnostic Systems, Inc. | 01/19/2006SE |
| K021582 | Bactec Mgit 960 Pza KitMJA · Traditional | Becton, Dickinson & CO | 07/13/2002SE |
| K003062 | Bactec Mgit 960 Sir KitsMJA · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 06/06/2001SE |
| K972772 | Esp Culture System II - Myco Susceptibility TestingMJA · Traditional | Trek Diagnostic Systems, Inc. | 07/13/1999SE |
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Questions and answers
When was Bactec Mgit 960 Sire Kits cleared by the FDA?
Bactec Mgit 960 Sire Kits (K014123) received a 510(k) decision of Substantially Equivalent on April 19, 2002, 123 days after the submission was received.
What is the product code of K014123?
The FDA product code is MJA – Susceptibility Test Powders, Antimycobacterial, a Class II (moderate risk) device regulated under 21 CFR 866.1640.