LCI · Automated Radioimmunoassay Systems, For Clinical Use
Clinical Chemistry · 21 CFR 862.2050 · Class 1
Overview
| Product Code | LCI |
|---|---|
| Device Name | Automated Radioimmunoassay Systems, For Clinical Use |
| Regulation | 21 CFR 862.2050 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
General purpose laboratory equipment labeled or promoted for a specific medical use is a device that is intended to prepare or examine specimens from the human body and that is labeled or promoted for a specific medical use.
Classification Rationale
Class I (general controls). The device is identified in paragraph (a) of this section and is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K983617 | 25-HYDROXYVITAMIN D 125I RIA KIT | DiaSorin, Inc. | Nov 16, 1998 | SESE |
| K801037 | CENTRIA SYSTEM 2 AUTOMATED METHOD/RIA | Union Carbide Corp. | May 28, 1980 | SESE |
| K780886 | SYSTEM 6000 AUTOMATED RIA ANALYZER | Beckman Instruments, Inc. | Sep 1, 1978 | SESE |
Top Applicants
- Beckman Instruments, Inc. — 1 clearance
- DiaSorin, Inc. — 1 clearance
- Union Carbide Corp. — 1 clearance
