THE SENSITITRE AIM
FDA 510(k) clearance K103456 · decided 2011-06-22
Clearance details
- K-number
- K103456
- Device name
- THE SENSITITRE AIM
- Applicant
- Trek Diagnostic Systems
- Decision
- Substantially Equivalent
- Date received
- 2010-11-24
- Decision date
- 2011-06-22
- Days to decision
- 210 days
- Clearance type
- Traditional
- Product code
- LIE
- Device class
- 2
- Regulation number
- 866.1640
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Cleveland, OH, 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 |
|---|---|---|
| MicroScan Prompt Inoculation System-D (K221493) | Beckman Coulter, Inc. | 2023-04-05 |
| SENSITITRE AIM (TM) (K110331) | Trek Diagnostic Systems, Ltd. | 2011-04-27 |
| SENSI-CAL AMCO AEPA-1 (K935566) | Radiometer America, Inc. | 1994-03-29 |
| TURBIDOMETRIC STANDARD (K911059) | Scientific Device Laboratory, Inc. | 1991-06-10 |
| DIFCO DIRECTOR INOCULATION SYSTEM (K890339) | Difco Laboratories, Inc. | 1989-02-07 |
| PROMPT INOCULATION SYSTEM (K820299) | 3M Company | 1982-03-15 |
Recalls involving this device
No recalls on record reference this clearance.