VERSATREK
FDA 510(k) clearance K032306 · decided 2003-08-22
Clearance details
- K-number
- K032306
- Device name
- VERSATREK
- Applicant
- Trek Diagnostic Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-07-25
- Decision date
- 2003-08-22
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- MDB
- Device class
- 1
- Regulation number
- 866.2560
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Cleveland, OH, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Trek Diagnostic Systems
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Thermo Scientific VersaTREK REDOX 1, Ref 7102-44, 80ml with Stir Bar (O2 aerobic), 50 bott recall (Z-2057-2014) | Remel Inc | 2014-07-15 |
| VersaTREK Windows Software, Version 5.4.3 is a component of the VersaTrek System. The Soft recall (Z-2323-2012) | Trek Diagnostic Systems | 2012-09-06 |
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 |