CJE · Class II · 21 CFR 862.1050

FDA Product Code CJE: Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes

Leading manufacturers include Em Diagnostic Systems, Inc., Harleco and Abbott Laboratories.

124
Total
124
Cleared
62d
Avg days
1976
Since
Growing category - 2 submissions in the last 2 years vs 1 in the prior period
Review times increasing: avg 247d recently vs 59d historically

FDA 510(k) Cleared Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes Devices (Product Code CJE)

124 devices
1–24 of 124
Cleared Dec 19, 2025
Tru Liver Health Test Panel
K251074
Truvian Health
Chemistry · 255d
Cleared Oct 16, 2024
Alkaline Phosphatase
K240468
Abbott Laboratories Diagnostics Division
Chemistry · 239d
Cleared Jul 21, 2023
Alkaline Phosphatase2
K223317
Abbott Ireland Diagnostics Division
Chemistry · 266d
Cleared Aug 30, 2019
Yumizen C1200 ALP, Yumizen C1200 Albumin
K191245
HORIBA ABX SAS
Chemistry · 113d
Cleared Jan 25, 2018
Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer
K171971
Lite-On Technology Corp. H.S.P.B.
Chemistry · 209d
Cleared May 10, 2017
ALP IFCC Gen.2
K171080
Roche Diagnostics Operations (Rdo)
Chemistry · 29d
Cleared Apr 21, 2017
Randox RX Daytona Plus Alkaline Phosphatase (ALP)
K162275
Randox Laboratories Limited
Chemistry · 252d
Cleared Aug 15, 2013
ACE ALKALINE PHOSPHATASE REAGENT, AMYLASE REAGENT, ALT REAGENT, AST REAGENT
K131351
Alfa Wassermann Diagnostic Technologies, LLC
Chemistry · 97d
Cleared Mar 22, 2013
S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE)
K130141
Hitachi Chemical Diagnostics, Inc.
Chemistry · 59d
Cleared Jul 12, 2012
ACE ALKALINE PHOSPHATASE REAGENT, ACE AMYLASE REAGENT, ACE LDH-L REAGENT
K113436
Alfa Wassermann
Chemistry · 234d
Cleared Dec 29, 2011
ELITTECH CLINICAL SYSTEMS ALP IFCC SL
K113269
Elitechgroup
Chemistry · 55d
Cleared May 20, 2011
EASYRA ALKALINE PHOSPHATASE, ASPARTATE AMINOTRANSFERASE AND AMYLASE REAGENTS
K101090
Medica Corp.
Chemistry · 396d
Cleared Jul 21, 2006
GENERAL CHEMISTRIES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER
K060205
Horiba Abx
Chemistry · 176d
Cleared Oct 14, 2003
COBAS INTEGRA ALP IFCC GEN.2
K033185
Roche Diagnostics Corp.
Chemistry · 13d
Cleared Dec 26, 2002
MODIFICATION TO ALKP
K023807
Abbott Laboratories
Chemistry · 42d
Cleared Jan 28, 2002
WIENER LAB. ALP 405
K013983
Wiener Laboratories Saic
Chemistry · 56d
Cleared Jul 20, 2001
ALKALINE PHOSPHATASE LIQUID REAGENT
K011599
Jas Diagnostics, Inc.
Chemistry · 57d
Cleared Nov 27, 2000
ALKALINE PHOSPHATASE-SL ASSAY, MODELS 328-17 AND 328-30
K003093
Diagnostic Chemicals , Ltd.
Chemistry · 55d
Cleared Jan 20, 2000
ALKALINE PHOSPHATASE LIQUID REAGENT-KINETIC, MODELS A504-150 AND A504-500H
K000067
Teco Diagnostics
Chemistry · 10d
Cleared Sep 02, 1999
ALKALINE PHOPHATASE (ALP), PRODUCT NO'S 118-01, 118-02
K991762
A.P. Total Care, Inc.
Chemistry · 101d
Cleared May 19, 1999
ELAN ALKALINE PHOSPHATE REAGENT KIT
K991387
Elan Holdings, Inc.
Chemistry · 28d
Cleared Jan 13, 1999
CARESIDE ALKALINE PHOSPHATASE
K990024
Careside, Inc.
Chemistry · 8d
Cleared Aug 26, 1998
ROCHE COBAS INTEGRA ALKALINE PHOSPHATASE IFCC LIQUID REAGENT CASSETTE, ROCHE COBAS INTEGRA PANCREATIC A-AMYLASE EPS REAE
K981897
Roche Diagnostic Systems, Inc.
Chemistry · 86d
Cleared Jun 22, 1998
ALKP
K981806
Abbott Laboratories
Chemistry · 32d

About Product Code CJE - Regulatory Context

510(k) Submission Activity

124 total 510(k) submissions under product code CJE since 1976, with 124 receiving FDA clearance (average review time: 62 days).

Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - CJE Product Code

Recent submissions under CJE have taken an average of 247 days to reach a decision - up from 59 days historically. Manufacturers should account for longer review timelines in current project planning.

CJE devices are reviewed by the Chemistry panel. Browse all Chemistry devices →