Panels › Clinical Chemistry › Product code LCI · Class 1
Automated Radioimmunoassay Systems, For Clinical Use
Regulation 862.2050
0510(k)s in 12 months (3 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in LCI
| Company | 510(k)s | Recalls |
|---|---|---|
| DiaSorin, Inc. | 1 | 1 |
| Beckman Instruments, Inc. | 1 | 0 |
| Union Carbide Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 16, 1998 | K983617 | 25-HYDROXYVITAMIN D 125I RIA KIT DiaSorin, Inc. | LCI |
| May 28, 1980 | K801037 | CENTRIA SYSTEM 2 AUTOMATED METHOD/RIA Union Carbide Corp. | LCI |
| Sep 1, 1978 | K780886 | SYSTEM 6000 AUTOMATED RIA ANALYZER Beckman Instruments, Inc. | LCI |
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