The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Bactec Mgit 960 Sir Kits.
| Device ID | K003062 |
| 510k Number | K003062 |
| Device Name: | BACTEC MGIT 960 SIR KITS |
| Classification | Susceptibility Test Powders, Antimycobacterial |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 7 LOVETON CIRCLE Sparks, MD 21152 -0999 |
| Contact | Dennis R Mertz |
| Correspondent | Dennis R Mertz BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 7 LOVETON CIRCLE Sparks, MD 21152 -0999 |
| Product Code | MJA |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-02 |
| Decision Date | 2001-06-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382902451266 | K003062 | 000 |
| 00382902451259 | K003062 | 000 |
| 00382902451235 | K003062 | 000 |