510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K841407Substantially Equivalent

Isogel Agarose

Fmc Corp., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K841407 is the FDA 510(k) clearance record for ISOGEL AGAROSE, a class I device, cleared for Fmc Corp. on under FDA product code JJN (Apparatus, Electrophoresis, For Clinical Use). FDA records list one 510(k) clearance for Fmc Corp. As of , FDA records show no recalls naming K841407.

Clearance record

Decision date
Received
(468 days to decision)
Product code
JJN Apparatus, Electrophoresis, For Clinical Use
Regulation
21 CFR 862.2485
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Fmc Corp. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code JJN

Trailing 12 months

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

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