Bactec Mgit 960 Sir Kits
FDA 510(k) K003062 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK003062
Submission
- Device name
- Bactec Mgit 960 Sir Kits
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Sparks, MD, US - Received
- October 2, 2000
- Decision date
- June 6, 2001
- 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 |
| K014123 | Bactec Mgit 960 Sire KitsMJA · Traditional | Becton, Dickinson & CO | 04/19/2002SE |
| K972772 | Esp Culture System II - Myco Susceptibility TestingMJA · Traditional | Trek Diagnostic Systems, Inc. | 07/13/1999SE |
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|---|---|---|
| K003553 | 0.9% Sodium Chloride Injection, Usp BD Pre-Filled Flush SyringeFOZ · Traditional | 03/21/2001SE |
| K003461 | BD Vacutainer Passive Shielding Blood Collection NeedleFMI · Traditional | 02/01/2001SE |
| K002938 | B-D Ultra-Fine III Pen Needle; Model 31G X 3/16FMI · Traditional | 11/29/2000SE |
| K001364 | BD Directigen Flu A+BPSZ · Traditional | 06/28/2000SE |
| K000762 | Moxifloxacin, 5 Ug, BBL Sensi-DiscJTN · Traditional | 04/25/2000SE |
| K000829 | Gatifloxacin, 5 Ug, BBL Sensi-DiscJTN · Traditional | 04/13/2000SE |
| K993186 | Synercid, 15 Ug, BBL Sensi-DiscJTN · Traditional | 11/03/1999SE |
| K992734 | Becton Dickinson SyringeMEG · Traditional | 10/01/1999SE |
| K992849 | QBC Star Centrifugal Hematology SystemGKZ · Special | 09/23/1999SE |
| K991551 | Vacutainer Brand Sodium Citrate Pediatric TubeJKA · Traditional | 09/23/1999SE |
Questions and answers
When was Bactec Mgit 960 Sir Kits cleared by the FDA?
Bactec Mgit 960 Sir Kits (K003062) received a 510(k) decision of Substantially Equivalent on June 6, 2001, 247 days after the submission was received.
What is the product code of K003062?
The FDA product code is MJA – Susceptibility Test Powders, Antimycobacterial, a Class II (moderate risk) device regulated under 21 CFR 866.1640.