510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K940037Substantially Equivalent

I.d. and Seakem Gtg Agaroses

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

K940037 is the FDA 510(k) clearance record for I.D. AND SEAKEM GTG AGAROSES, a class I device, cleared for Fmc Corp. on under FDA product code JZR (Support Gels). FDA records list one 510(k) clearance for Fmc Corp. As of , FDA records show no recalls naming K940037.

Clearance record

Decision date
Received
(416 days to decision)
Product code
JZR Support Gels
Regulation
21 CFR 866.4900
Device class
Class I
Review panel
Immunology
Applicant
Fmc Corp. 1001 G St., NW, Washington DC
510(k) summary
Statement
Third party review
No

Clearances, product code JZR

Trailing 12 months

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

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