510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K080485Substantially Equivalent

Aspartate Amino Transferase (Ast/sgot) Test System, Asat (Got) Fs

Diasys Diagnostics Systems GmbH, Holzheim, Rheinland-Pfalz, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080485 is the FDA 510(k) clearance record for ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS, a class II device, cleared for Diasys Diagnostics Systems GmbH on under FDA product code CIT (Nadh Oxidation/Nad Reduction, Ast/Sgot). FDA records list one 510(k) clearance for Diasys Diagnostics Systems GmbH. As of , FDA records show no recalls naming K080485.

Clearance record

Decision date
Received
(286 days to decision)
Product code
CIT Nadh Oxidation/Nad Reduction, Ast/Sgot
Regulation
21 CFR 862.1100
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Diasys Diagnostics Systems GmbH Alte Strasse 9, Holzheim, Rheinland-Pfalz, DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CIT

Trailing 12 months

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

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