510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K983880Substantially Equivalent

Transferrin Spq III Antibody Reagent Set

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

K983880 is the FDA 510(k) clearance record for TRANSFERRIN SPQ III ANTIBODY REAGENT SET, a class II device, cleared for DiaSorin, Inc. on under FDA product code DDG (Transferrin, Antigen, Antiserum, Control). FDA records list 74 510(k) clearances for DiaSorin, Inc., from to . As of , FDA records show no recalls naming K983880.

Clearance record

Decision date
Received
(46 days to decision)
Product code
DDG Transferrin, Antigen, Antiserum, Control
Regulation
21 CFR 866.5880
Device class
Class II
Review panel
Immunology
Applicant
DiaSorin, Inc. 9175 Guiford Rd., Columbia MD
510(k) summary
Summary
Third party review
No

Clearances, product code DDG

Trailing 12 months

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

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