510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K983617Substantially Equivalent

25-Hydroxyvitamin D 125I Ria Kit

Diasorin Inc., Columbia MD / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K983617 is the FDA 510(k) clearance record for 25-HYDROXYVITAMIN D 125I RIA KIT, a class I device, cleared for DiaSorin, Inc. on under FDA product code LCI (Automated Radioimmunoassay Systems, For Clinical Use). FDA records list 74 510(k) clearances for DiaSorin, Inc., from to . As of , FDA records show one recall naming K983617.

Clearance record

Decision date
Received
(32 days to decision)
Product code
LCI Automated Radioimmunoassay Systems, For Clinical Use
Regulation
21 CFR 862.2050
Device class
Class I
Review panel
Clinical Chemistry
Applicant
DiaSorin, Inc. 9175 Guiford Rd., Columbia MD
510(k) summary
Summary
Third party review
No

Clearances, product code LCI

Trailing 12 months

FDA records hold no clearances under product code LCI in the trailing twelve months.

FDA records show no clearances under product code LCI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LCI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260