Cleared Traditional

CREATININE 340 (ENZYMATIC)

K895847 · Sclavo, Inc. · Chemistry
Oct 1989
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K895847 is an FDA 510(k) clearance for the CREATININE 340 (ENZYMATIC), a Alkaline Picrate, Colorimetry, Creatinine (Class II — Special Controls, product code CGX), submitted by Sclavo, Inc. (Wayne, US). The FDA issued a Cleared decision on October 30, 1989, 27 days after receiving the submission on October 3, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1225.

Submission Details

510(k) Number K895847 FDA.gov
FDA Decision Cleared SESE
Date Received October 03, 1989
Decision Date October 30, 1989
Days to Decision 27 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CGX — Alkaline Picrate, Colorimetry, Creatinine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1225

Similar Devices — CGX Alkaline Picrate, Colorimetry, Creatinine

All 158
Nova Allegro UACR Assay, Nova Allegro Analyzer
K252206 · Nova Biomedical Corporation · Jan 2026
Tru Kidney Health Test Panel; Tru Analyzer
K251058 · Truvian Health · Nov 2025
Atellica? CH Creatinine_3 (Crea3)
K242685 · Siemens Healthcare Diagnostics, Inc. · Dec 2024
Nova Allegro UACR Assay, Nova Allegro Analyzer
K221813 · Nova Biomedical Corporation · Nov 2024
Creatinine2
K210452 · Abbott Ireland Diagnostics Division · Mar 2022
Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)
K161494 · Siemens Healthcare Diagnostics, Inc. · Nov 2016