TURBIDOMETRIC STANDARD
FDA 510(k) clearance K911059 · decided 1991-06-10
Clearance details
- K-number
- K911059
- Device name
- TURBIDOMETRIC STANDARD
- Applicant
- Scientific Device Laboratory, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-03-11
- Decision date
- 1991-06-10
- Days to decision
- 91 days
- Clearance type
- Traditional
- Product code
- LIE
- Device class
- 2
- Regulation number
- 866.1640
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Glenview, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Scientific Device Laboratory
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.
| Record | Firm | Date |
|---|---|---|
| MicroScan Prompt Inoculation System-D (K221493) | Beckman Coulter, Inc. | 2023-04-05 |
| THE SENSITITRE AIM (K103456) | Trek Diagnostic Systems | 2011-06-22 |
| SENSITITRE AIM (TM) (K110331) | Trek Diagnostic Systems, Ltd. | 2011-04-27 |
| SENSI-CAL AMCO AEPA-1 (K935566) | Radiometer America, Inc. | 1994-03-29 |
| 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.