Sensititre 18-24 HR Susceptibility Plates(Addition of Meropenem)
FDA 510(k) K983244 · Trek Diagnostic Systems, Inc.
510(k) numberK983244
Submission
- Device name
- Sensititre 18-24 HR Susceptibility Plates(Addition of Meropenem)
- Applicant
- Trek Diagnostic Systems, Inc.
Cleveland, OH, US - Received
- September 16, 1998
- Decision date
- November 30, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JTW – System, Transport, Aerobic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2900
- Specialty
- Microbiology
Other 510(k)s with product code JTW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K121039 | Copan Mswab Collection, Transport and Preservation SystemJTW · Traditional | Copan Flock Technologies | 05/25/2012SE |
| K061301 | Copan Liquid Amies Elution Swab (Eswab) Collection and Transport SystemJTW · Traditional | Copan Diagnostics, Inc. | 06/23/2006SE |
| K022874 | Gen-Probe Aptima Combo 2 AssayJTW · Traditional | Gen-Probe, Inc. | 09/17/2002SE |
| K013819 | Urine Collection, Preservation and Transport SystemJTW · Traditional | Sierra Diagnostic, LLC | 02/28/2002SE |
| K993161 | Copan Easy-Swab Collection and Transport SystemJTW · Traditional | Copan Diagnostics, Inc. | 11/09/1999SE |
| K961148 | Cefepime Dispans-O-Disc (Cefeplime - 30MCG)JTW · Traditional | Difco Laboratories, Inc. | 04/26/1996SE |
| K934894 | Cultureswab Transport SystemJTW · Traditional | Difco Laboratories, Inc. | 02/22/1994SE |
| K904773 | P and T MediumJTW · Traditional | Gibson Laboratories, Inc. | 12/04/1990SE |
| K895187 | FDL, Inc.'s Transport SystemJTW · Traditional | Fairleigh Dickinson Laboratories, Inc. | 10/24/1989SE |
| K882580 | Mechanical Change in In-Vitro Micro DeviceJTW · Traditional | Precision Dynamics Corp. | 07/08/1988SE |
More from Precision Dynamics Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K133038 | Sensititre Yeastone Susceptibility PlatesNGZ · Traditional | 01/31/2014SE |
| K112276 | VizionJWY · Traditional | 11/16/2011SE |
| K111615 | Sensititre 18-24 HR Susceptibility PlatesJWY · Traditional | 11/08/2011SE |
| K110583 | Sensititre OptireadLRG · Traditional | 09/22/2011SE |
| K103532 | Autoreader 2LRG · Traditional | 08/26/2011SE |
| K111429 | Sensititre (R) HP Mic Susceptibility Plate with Cefaroline (0.004-8UG/ML) and the…JWY · Traditional | 08/18/2011SE |
| K103456 | The Sensititre AimLIE · Traditional | 06/22/2011SE |
| K110331 | Sensititre Aim (TM)LIE · Traditional | 04/27/2011SE |
| K093741 | Sensitive Haemophilus Influenzae, Streptococcus Pneumonia, (HP) Mic Susceptibility PlatesJWY · Traditional | 02/25/2010SE |
| K093865 | Sensititre 18-24HR Susceptibility PlatesJWY · Traditional | 02/17/2010SE |
Questions and answers
When was Sensititre 18-24 HR Susceptibility Plates(Addition of Meropenem) cleared by the FDA?
Sensititre 18-24 HR Susceptibility Plates(Addition of Meropenem) (K983244) received a 510(k) decision of Substantially Equivalent on November 30, 1998, 75 days after the submission was received.
What is the product code of K983244?
The FDA product code is JTW – System, Transport, Aerobic, a Class I (low risk) device regulated under 21 CFR 866.2900.