510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K963498Substantially Equivalent

Ferr Flex Reagent Cartridge

Dade Chemistry Systems, Inc., Newark DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963498 is the FDA 510(k) clearance record for FERR FLEX REAGENT CARTRIDGE, a class II device, cleared for Dade Chemistry Systems, Inc. on under FDA product code JMG (Radioimmunoassay (Two-Site Solid Phase), Ferritin). FDA records list 13 510(k) clearances for Dade Chemistry Systems, Inc., from to . As of , FDA records show 3 recalls naming K963498.

Clearance record

Decision date
Received
(143 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
Dade Chemistry Systems, Inc. P.O. Box 6101, Glasgow Bldg., Newark DE
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