510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K042919Substantially Equivalent

Fibrotek Fib

R2 Diagnostics, Inc., South Bend IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K042919 is the FDA 510(k) clearance record for FIBROTEK FIB, a class II device, cleared for R2 Diagnostics, Inc. on under FDA product code GIS (Test, Fibrinogen). FDA records list 10 510(k) clearances for R2 Diagnostics, Inc., from to . As of , FDA records show no recalls naming K042919.

Clearance record

Decision date
Received
(38 days to decision)
Product code
GIS Test, Fibrinogen
Regulation
21 CFR 864.7340
Device class
Class II
Review panel
Hematology
Applicant
R2 Diagnostics, Inc. 412 S. Lafayette Blvd., South Bend IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GIS

Trailing 12 months

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

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