Reagent/Device, Inoculum Calibration
An inoculum calibration reagent or device is a microbiological laboratory tool used to standardize the concentration of bacterial inocula for antimicrobial susceptibility testing and other procedures requiring a defined microbial density, ensuring reproducibility and accuracy of results. The device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. It carries product code LIE and is regulated under 21 CFR 866.1640 within the Microbiology specialty. This device is eligible for third-party review.
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Basic Information
- Product Code
- LIE
- Device Class
- FDA class 2
- Regulation Number
- 866.1640
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K221493 | MicroScan Prompt Inoculation System-D | Apr 05, 2023 | Substantially Equivalent | Beckman Coulter, Inc. |
| K103456 | THE SENSITITRE AIM | Jun 22, 2011 | Substantially Equivalent | Trek Diagnostic Systems |
| K110331 | SENSITITRE AIM (TM) | Apr 27, 2011 | Substantially Equivalent | Trek Diagnostic Systems, Ltd. |
| K935566 | SENSI-CAL AMCO AEPA-1 | Mar 29, 1994 | Substantially Equivalent | Radiometer America, Inc. |
| K911059 | TURBIDOMETRIC STANDARD | Jun 10, 1991 | Substantially Equivalent | Scientific Device Laboratory, Inc. |
| K890339 | DIFCO DIRECTOR INOCULATION SYSTEM | Feb 07, 1989 | Substantially Equivalent | Difco Laboratories, Inc. |
| K820299 | PROMPT INOCULATION SYSTEM | Mar 15, 1982 | Substantially Equivalent | 3M Company |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.