# Trek Diagnostic Systems, Inc.

- Location (FDA's records): Cleveland, OH
- FDA decisions: 69 (1979–2014): 68 510(k) clearances and 1 original PMA approval
- Names in FDA's records: Trek Diagnostic Systems, Inc. (57); Trek Diagnostic Systems, Ltd. (7); Trek Diagnostic Systems (5)
- Product codes: JWY (51), NGZ (4), LTT (4), LRG (3), LIE (2), MJA (2), JTW (1), LON (1), MDB (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 3 (0 its own)
- Recalls linked to its devices: 13 (9 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Bd Becton Dickinson Vacutainer Systems Preanalytic: 1 (https://510kreport.com/company/bd-becton-dickinson-vacutainer-systems-preanalytic)

## Firms that cite its devices most
- Becton, Dickinson & CO: 2 (https://510kreport.com/company/becton-dickinson)
- bioMerieux, Inc.: 1 (https://510kreport.com/company/biomerieux)

## Its most-cited devices
- K991810: Modification to Sensititre Yeastone Mic Susceptibility Test (2001), cited by 1
- K073653: Sensititre 18 - 24 Hour Susceptibility Plate (2008), cited by 1
- K031545: Sensititre 18-24 Hour Susceptibility Plate (2003), cited by 1

## Recent decisions
- K133038: Sensititre Yeastone Susceptibility Plates (Jan 31, 2014)
- K112276: Vizion (Nov 16, 2011)
- K111615: Sensititre 18-24 HR Susceptibility Plates (Nov 8, 2011)
- K110583: Sensititre Optiread (Sep 22, 2011)
- K103532: Autoreader 2 (Aug 26, 2011)
- K111429: Sensititre (R) HP Mic Susceptibility Plate with Cefaroline (0.004-8UG/ML) and the Sensititre (R) 18-24 Hour Mic Susce... (Aug 18, 2011)
- K103456: The Sensititre Aim (Jun 22, 2011)
- K110331: Sensititre Aim (TM) (Apr 27, 2011)

Source page: https://510kreport.com/company/trek-diagnostic-systems