510(k) K983617

Device: 25-HYDROXYVITAMIN D 125I RIA KIT
Applicant: DIASORIN, INC.
510(k) number: K983617
Product code: LCI
Decision: Substantially Equivalent (SESE)
Decision date: 1998-11-16
Date received: 1998-10-15
Regulation: 862.2050
Classification name: Automated Radioimmunoassay Systems, For Clinical Use
Medical specialty: Clinical Chemistry
Review panel: Clinical Chemistry
Device class: 1
Clearance type: Special
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: JUDITH J SMITH
Address: 9175 Guiford Rd. Columbia MD US 21046 21046

Source Documents#

Other 510(k) Records For Product Code LCI #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
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

Legacy Summary#

summary

FDA Review#

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