VERSATREK— 510(k) K032306
Substantially EquivalentTrek Diagnostic Systems, Inc.
FDA 510(k) clearance K032306 for VERSATREK, Substantially Equivalent on 2003-08-22. Applicant: Trek Diagnostic Systems, Inc.. Device class: 1.
Clearance details
- Applicant
- Trek Diagnostic Systems, Inc.
- Product code
- Code MDB
- Device class
- Class 1
- Regulation
- 21 CFR 866.2560
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Cleveland, OH, US
Recent devices under product code MDB
view allMore clearances from Trek Diagnostic Systems, Inc.
view allAdverse events under product code MDB
product code MDB- Death
- 6
- Malfunction
- 5,490
- Total
- 5,496
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K032306
K-number listed on FDA's recall record- Z-2057-2014 — Thermo Scientific VersaTREK REDOX 1, Ref 7102-44, 80ml with Stir Bar (O2 aerobic), 50 bottles/box, IVD. The firm name on the label is Remel Inc., Lenexa, KS.
- Z-2323-2012 — VersaTREK Windows Software, Version 5.4.3 is a component of the VersaTrek System. The Software CD will be individually packaged using a standard CD plastic case and placed into a standard CD mailer The VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile body fluids.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K032306.
Data sourced from openFDA. This site is unofficial and independent of the FDA.