510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K924186Substantially Equivalent

Lpia-Ferritin Assay

Seradyn, Inc., Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K924186 is the FDA 510(k) clearance record for LPIA-FERRITIN ASSAY, a class I device, cleared for Seradyn, Inc. on under FDA product code DEF (Alpha-2-Hs-Glycoprotein, Antigen, Antiserum, Control). FDA records list 30 510(k) clearances for Seradyn, Inc., from to . As of , FDA records show no recalls naming K924186.

Clearance record

Decision date
Received
(125 days to decision)
Product code
DEF Alpha-2-Hs-Glycoprotein, Antigen, Antiserum, Control
Regulation
21 CFR 866.5425
Device class
Class I
Review panel
Immunology
Applicant
Seradyn, Inc. P.O. Box 1210, Indianapolis IN
510(k) summary
Summary
Third party review
No

Clearances, product code DEF

Trailing 12 months

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

FDA records show no clearances under product code DEF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DEF, 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