510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K050817Substantially Equivalent

T-Tek

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

K050817 is the FDA 510(k) clearance record for T-TEK, a class II device, cleared for R2 Diagnostics, Inc. on under FDA product code GJA (Test, Thrombin Time). FDA records list 10 510(k) clearances for R2 Diagnostics, Inc., from to . As of , FDA records show no recalls naming K050817.

Clearance record

Decision date
Received
(256 days to decision)
Product code
GJA Test, Thrombin Time
Regulation
21 CFR 864.7875
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 GJA

Trailing 12 months

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

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