510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K811589Substantially Equivalent

Actin Fs Activated Ptt Reagent

American Dade, Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K811589 is the FDA 510(k) clearance record for ACTIN FS ACTIVATED PTT REAGENT, a class II device, cleared for American Dade on under FDA product code GGW (Test, Time, Partial Thromboplastin). FDA records list 149 510(k) clearances for American Dade, from to . As of , FDA records show one recall naming K811589.

Clearance record

Decision date
Received
(38 days to decision)
Product code
GGW Test, Time, Partial Thromboplastin
Regulation
21 CFR 864.7925
Device class
Class II
Review panel
Hematology
Applicant
American Dade 4221 Richmond Rd., NW, Walker MI
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