510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K993547Substantially Equivalent

Beckman Coulter Immage Immunochemistry System Low Concentration Immunoglobulin M (Igmlc) Reagent, Beckman Coulter Cereb

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

K993547 is the FDA 510(k) clearance record for BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN M (IGMLC) REAGENT, BECKMAN COULTER CEREB, a class II device, cleared for Beckman Coulter, Inc. on under FDA product code CFN (Method, Nephelometric, Immunoglobulins (G, A, M)). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics Inc., from to . As of , FDA records show one recall naming K993547.

Clearance record

Decision date
Received
(105 days to decision)
Product code
CFN Method, Nephelometric, Immunoglobulins (G, A, M)
Regulation
21 CFR 866.5510
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 CFN

Trailing 12 months

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

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