The following data is part of a premarket notification filed by Becton, Dickinson & Co. with the FDA for Bactec Mgit 960 Pza Kit.
| Device ID | K021582 |
| 510k Number | K021582 |
| Device Name: | BACTEC MGIT 960 PZA KIT |
| Classification | Susceptibility Test Powders, Antimycobacterial |
| Applicant | BECTON, DICKINSON & CO. 7 LOVETON CIR. Sparks, MD 21152 -0999 |
| Contact | Michelle B Bandy |
| Correspondent | Michelle B Bandy BECTON, DICKINSON & CO. 7 LOVETON CIR. 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 | 2002-05-14 |
| Decision Date | 2002-07-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382902451280 | K021582 | 000 |
| 30382902451151 | K021582 | 000 |