510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K090105Substantially Equivalent

Lupotek Kct

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

K090105 is the FDA 510(k) clearance record for LUPOTEK KCT, a class II device, cleared for R2 Diagnostics, Inc. on under FDA product code GGW (Test, Time, Partial Thromboplastin). FDA records list 10 510(k) clearances for R2 Diagnostics, Inc., from to . As of , FDA records show no recalls naming K090105.

Clearance record

Decision date
Received
(714 days to decision)
Product code
GGW Test, Time, Partial Thromboplastin
Regulation
21 CFR 864.7925
Device class
Class II
Review panel
Hematology
Applicant
R2 Diagnostics, Inc. 1801 Commerce Dr., South Bend IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GGW

Trailing 12 months
1 clearance under product code GGW in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GGW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260