510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K926221Substantially Equivalent

Access Ferritin Assay

Bio-Rad Laboratories Inc., Chaska MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K926221 is the FDA 510(k) clearance record for ACCESS FERRITIN ASSAY, a class II device, cleared for Bio-Rad Laboratories, Inc. on under FDA product code JMG (Radioimmunoassay (Two-Site Solid Phase), Ferritin). FDA records list 128 510(k) clearances for Bio-Rad Laboratories, Inc., from to . As of , FDA records show one recall naming K926221.

Clearance record

Decision date
Received
(34 days to decision)
Product code
JMG Radioimmunoassay (Two-Site Solid Phase), Ferritin
Regulation
21 CFR 866.5340
Device class
Class II
Review panel
Immunology
Applicant
Bio-Rad Laboratories, Inc. 1000 Lake Hazeltine Dr., Chaska MN
510(k) summary
Summary
Third party review
No

Clearances, product code JMG

Trailing 12 months

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

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