Cleared Traditional

KINETIC ALKALINE PHOSPHATASE DETERMINATION

K905650 · Biochemical Trade, Inc. · Chemistry
Feb 1991
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K905650 is an FDA 510(k) clearance for the KINETIC ALKALINE PHOSPHATASE DETERMINATION, a Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (Class II — Special Controls, product code CJE), submitted by Biochemical Trade, Inc. (Miami, US). The FDA issued a Cleared decision on February 13, 1991, 57 days after receiving the submission on December 18, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1050.

Submission Details

510(k) Number K905650 FDA.gov
FDA Decision Cleared SESE
Date Received December 18, 1990
Decision Date February 13, 1991
Days to Decision 57 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CJE — Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1050

Similar Devices — CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes

All 123
Tru Liver Health Test Panel
K251074 · Truvian Health · Dec 2025
Alkaline Phosphatase
K240468 · Abbott Laboratories Diagnostics Division · Oct 2024
Alkaline Phosphatase2
K223317 · Abbott Ireland Diagnostics Division · Jul 2023
Yumizen C1200 ALP, Yumizen C1200 Albumin
K191245 · HORIBA ABX SAS · Aug 2019
Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer
K171971 · Lite-On Technology Corp. H.S.P.B. · Jan 2018
ALP IFCC Gen.2
K171080 · Roche Diagnostics Operations (Rdo) · May 2017