VERSATREK MYCO PZA KIT
FDA 510(k) clearance K052323 · decided 2006-01-19
Clearance details
- K-number
- K052323
- Device name
- VERSATREK MYCO PZA KIT
- Applicant
- Trek Diagnostic Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-08-25
- Decision date
- 2006-01-19
- Days to decision
- 147 days
- Clearance type
- Traditional
- Product code
- MJA
- Device class
- 2
- Regulation number
- 866.1640
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Sun Prairie, WI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BACTEC MGIT 960 PZA KIT (K021582) | Becton, Dickinson & CO | 2002-07-13 |
| BACTEC MGIT 960 SIRE KITS (K014123) | Becton, Dickinson & CO | 2002-04-19 |
| BACTEC MGIT 960 SIR KITS (K003062) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 2001-06-06 |
| ESP CULTURE SYSTEM II - MYCO SUSCEPTIBILITY TESTING (K972772) | Trek Diagnostic Systems, Inc. | 1999-07-13 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| SENSITITRE (N50531/S007) | Trek Diagnostic Systems, Inc. | 1984-03-07 |
| SENSITITRE (N50531/S006) | Trek Diagnostic Systems, Inc. | 1983-02-17 |
| SENSITITRE (N50531/S005) | Trek Diagnostic Systems, Inc. | 1982-04-08 |
| SENSITITRE (N50531/S004) | Trek Diagnostic Systems, Inc. | 1981-04-14 |
| SENSITITRE (N50531/S003) | Trek Diagnostic Systems, Inc. | 1980-08-13 |
| SENSITITRE (N50531) | Trek Diagnostic Systems, Inc. | 1979-05-04 |