510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K994110Substantially Equivalent

Lipoprotein (a) Spq III Antibody Reagent Set

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

K994110 is the FDA 510(k) clearance record for LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET, a class II device, cleared for Diasorin/American Standard Companies on under FDA product code DFC (Lipoprotein, Low-Density, Antigen, Antiserum, Control). FDA records list one 510(k) clearance for Diasorin/American Standard Companies. As of , FDA records show no recalls naming K994110.

Clearance record

Decision date
Received
(15 days to decision)
Product code
DFC Lipoprotein, Low-Density, Antigen, Antiserum, Control
Regulation
21 CFR 866.5600
Device class
Class II
Review panel
Immunology
Applicant
Diasorin/American Standard Companies 9175 Guilford Rd.., Suite 100, Columbia MD
510(k) summary
Summary
Third party review
No

Clearances, product code DFC

Trailing 12 months
1 clearance under product code DFC in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DFC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260