510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K000121Substantially Equivalent

Immage Immunochemistry System Lipoprotein(a) Lpax Reagent, Array System Lipoprotein(a) Lpa Reagent, Lipoprotein(a) Calib

Siemens Healthcare Diagnostics Inc., Brea CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K000121 is the FDA 510(k) clearance record for IMMAGE IMMUNOCHEMISTRY SYSTEM LIPOPROTEIN(A) LPAX REAGENT, ARRAY SYSTEM LIPOPROTEIN(A) LPA REAGENT, LIPOPROTEIN(A) CALIB, a class II device, cleared for Beckman Coulter, Inc. on under FDA product code DFC (Lipoprotein, Low-Density, Antigen, Antiserum, Control). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics Inc., from to . As of , FDA records show no recalls naming K000121.

Clearance record

Decision date
Received
(120 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
Beckman Coulter, Inc. 200 S. Kraemer Blvd.,M/S W-104, Brea CA
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 November 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DFC, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260
November 20260