510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K071580Substantially Equivalent

Ast/got (Ifcc), Pyridoxal Phosphate, Ecal, Nortrol and Abtrol

Thermofisher Scientific Oy, Vantaa, FI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K071580 is the FDA 510(k) clearance record for AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROL, a class II device, cleared for Thermofisher Scientific OY on under FDA product code CIT (Nadh Oxidation/Nad Reduction, Ast/Sgot). FDA records list 8 510(k) clearances for Thermofisher Scientific OY, from to . As of , FDA records show no recalls naming K071580.

Clearance record

Decision date
Received
(117 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
Thermofisher Scientific OY 2 Ratastie, Vantaa, FI
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