510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K994341Substantially Equivalent

Fibrinogen Calibrator Kit

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

K994341 is the FDA 510(k) clearance record for FIBRINOGEN CALIBRATOR KIT, a class II device, cleared for Dade Behring, Inc. on under FDA product code GFX (Fibrinogen Standard). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics Inc., from to . As of , FDA records show no recalls naming K994341.

Clearance record

Decision date
Received
(71 days to decision)
Product code
GFX Fibrinogen Standard
Regulation
21 CFR 864.7340
Device class
Class II
Review panel
Hematology
Applicant
Dade Behring, Inc. P.O. Box 6101, Newark DE
510(k) summary
Summary
Third party review
No

Clearances, product code GFX

Trailing 12 months

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

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