510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K923641Substantially Equivalent

Il Test Ast, Pn 35312

Instrumentation Laboratory Co., Lexington MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K923641 is the FDA 510(k) clearance record for IL TEST AST, PN 35312, a class II device, cleared for Instrumentation Laboratory CO on under FDA product code CIT (Nadh Oxidation/Nad Reduction, Ast/Sgot). FDA records list 327 510(k) clearances for Instrumentation Laboratory CO, from to . As of , FDA records show no recalls naming K923641.

Clearance record

Decision date
Received
(97 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
Instrumentation Laboratory CO 113 Hartwell Ave., Lexington MA
510(k) summary
Summary
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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CIT, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260