MULTIGENT CREATININE (ENZYMATIC) ASSAY— 510(k) K073634

Clearance details

Applicant

SENTINEL CH. SpA

Product code

Code JFY

Device class

Class 2

Regulation

21 CFR 862.1225

Advisory panel

Clinical Chemistry

Date received

2007-12-26

Decision date

2008-06-19

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Milan, IT

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• Z-2867-2017 — MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41; IVD. Intended for the quantitative determination of creatinine in human serum, plasma, and urine using the ARCHITECT c Systems The product is a medical device (chemistry reagent) and is intended for the quantitative determination of creatinine in human serum, plasma, and urine using the ARCHITECT c Systems. The kit is provided as a ready to use liquid material consisting in two components: Reagent 1 and Reagent 2. According to the catalogue number, the kit is composed of three vials of 48 ml for Reagent 1 and three vials of 18 ml for Reagent 2 in the configuration 8L24-31. The configuration 8L24-41 consists in ten vials of 90 ml for Reagent 1 and ten vials of 34 ml for Reagent 2Class II·Terminated·Sentinel CH SPA·20170522

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K073634.