Automated Radioimmunoassay Systems, For Clinical Use
Automated radioimmunoassay systems for clinical use are laboratory platforms that use radiolabeled reagents to automate the measurement of hormones, drugs, or other analytes in patient specimens, offering high throughput and precision in clinical chemistry workflows. They are classified as FDA Class 1, the lowest risk tier, subject only to general controls with no premarket notification required. The product code is LCI, regulated under 21 CFR 862.2050, in the Clinical Chemistry specialty. Third-party review is available for this device.
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Basic Information
- Product Code
- LCI
- Device Class
- FDA class 1
- Regulation Number
- 862.2050
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K983617 | 25-HYDROXYVITAMIN D 125I RIA KIT | Nov 16, 1998 | Substantially Equivalent | DiaSorin, Inc. |
| K801037 | CENTRIA SYSTEM 2 AUTOMATED METHOD/RIA | May 28, 1980 | Substantially Equivalent | Union Carbide Corp. |
| K780886 | SYSTEM 6000 AUTOMATED RIA ANALYZER | Sep 01, 1978 | Substantially Equivalent | Beckman Instruments, Inc. |