Product code LCI

Device name: Automated Radioimmunoassay Systems, For Clinical Use
Medical specialty: Clinical Chemistry
Device class: 1
Regulation number: 862.2050
Review panel: CH
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: Y
Summary malfunction reporting: Eligible
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K983617	25-HYDROXYVITAMIN D 125I RIA KIT	DiaSorin, Inc.	1998-11-16
K801037	CENTRIA SYSTEM 2 AUTOMATED METHOD/RIA	Union Carbide Corp.	1980-05-28
K780886	SYSTEM 6000 AUTOMATED RIA ANALYZER	Beckman Instruments, Inc.	1978-09-01