510(k) K021582
- Device
- BACTEC MGIT 960 PZA KIT
- Applicant
- BECTON, DICKINSON & CO.
- 510(k) number
- K021582
- Product code
- MJA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-07-13
- Date received
- 2002-05-14
- Regulation
- 866.1640
- Classification name
- Susceptibility Test Powders, Antimycobacterial
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MICHELLE B BANDY
- Address
- 7loveton Cir. Sparks MD US 21152 21152
FDA Registration Numbers#
- 1924669
- 1119779
- 1111096
Source Documents#
Other 510(k) Records For Product Code MJA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K052323 | VERSATREK MYCO PZA KIT | Trek Diagnostic Systems, Inc. | 2006-01-19 |
| K014123 | BACTEC MGIT 960 SIRE KITS | Becton, Dickinson & CO | 2002-04-19 |
| K003062 | BACTEC MGIT 960 SIR KITS | Bd Becton Dickinson Vacutainer Systems Preanalytic | 2001-06-06 |
| K972772 | ESP CULTURE SYSTEM II - MYCO SUSCEPTIBILITY TESTING | Trek Diagnostic Systems, Inc. | 1999-07-13 |
Legacy Summary#
summary
FDA Review#
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