510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN230024Unknown

Technozym ADAMTS13 Activity

Technoclone Herstellung von Diagnostika und Arzneimitteln GM, Vienna, AT / Direct, Unknown
FDA source (opens on fda.gov)

DEN230024 is the FDA 510(k) clearance record for Technozym ADAMTS13 Activity, a class II device, cleared for Technoclone Herstellung Von Diagnostika Und Arzneimitteln GM on under FDA product code SAC (Adamts13 Activity Test System). FDA's definition for product code SAC reads: "An ADAMTS13 activity test system is a qualitative or quantitative in vitro diagnostic device intended to detect ADAMTS13 activity in human blood specimens collected from patients being evaluated for thrombotic microangiopathy. This device...". FDA records list one 510(k) clearance for Technoclone Herstellung Von Diagnostika Und Arzneimitteln GM. As of , FDA records show no recalls naming DEN230024.

Clearance record

Decision date
Received
(328 days to decision)
Product code
SAC Adamts13 Activity Test System
Regulation
21 CFR 864.7297
Device class
Class II
Review panel
Hematology
Applicant
Technoclone Herstellung Von Diagnostika Und Arzneimitteln GM Brunner Strasse 67, Vienna, AT
Third party review
No

Clearances, product code SAC

Trailing 12 months

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

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