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 20, 2011
EASYRA ALKALINE PHOSPHATASE, ASPARTATE AMINOTRANSFERASE AND AMYLASE REAGENTS
K101090
Medica Corp.
Chemistry · 396d
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 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 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
Cleared May 20, 1998
ALKALINE PHOSPHATASE (ALKP)
K981245
Abbott Laboratories
Chemistry · 44d
Cleared Feb 12, 1998
ALKALINE PHOSPHATASE-SL ASSAY CATALOGUE NUMBER 309-10, 309-30
K980316
Diagnostic Chemicals , Ltd.
Chemistry · 16d
Cleared Oct 22, 1997
LIQUID ALKALINE PHOSHATASE REAGENT SET
K973588
Pointe Scientific, Inc.,
Chemistry · 30d
Cleared Feb 28, 1996
ALKALINE PHOSPHATASE (ALP) PROCEDURE NO. 245
K954840
Sigma Diagnostics, Inc.
Chemistry · 131d
Cleared Nov 27, 1995
ALKALINE PHOSPHATASE REAGENT SYSTEM
K952746
Medical Diagnostic Technologies, Inc.
Chemistry · 164d
Cleared Aug 11, 1995
ALKALINE PHOSPHATASE (ALP/AMP) PROCEDURE NO. 247
K951584
Sigma Diagnostics, Inc.
Chemistry · 127d
Cleared May 17, 1994
STANBIO ALKALINE PHOSPHATASE (LIQUICOLOR) TEST SET
K941313
Stanbio Laboratory
Chemistry · 60d
Cleared Dec 09, 1993
EMDS ALKANINE PHOSPHATASE (ALP) TEST
K935182
Em Diagnostic Systems, Inc.
Chemistry · 43d
Cleared Sep 08, 1993
AMP ALKALINE PHOSPHATASE REAGENT KIT
K931986
Synermed, Inc.
Chemistry · 139d
Cleared Dec 03, 1992
ALKALINE PHOSPHATASE KIT
K923507
Randox Laboratories, Ltd.
Chemistry · 141d
Cleared Nov 18, 1992
OLYMPUS ALKALINE PHOSPHATASE REAGENT
K925156
Olympus Corp.
Chemistry · 36d
Cleared Nov 09, 1992
EMDS ALKALINE PHOSPHATASE (ALP) TEST
K924574
Em Diagnostic Systems, Inc.
Chemistry · 60d

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 →