CJE · Class II · 21 CFR 862.1050

FDA Product Code CJE: Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes

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

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 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 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 Dec 09, 1993
EMDS ALKANINE PHOSPHATASE (ALP) TEST
K935182
Em Diagnostic Systems, Inc.
Chemistry · 43d
Cleared Nov 09, 1992
EMDS ALKALINE PHOSPHATASE (ALP) TEST
K924574
Em Diagnostic Systems, Inc.
Chemistry · 60d
Cleared Nov 22, 1991
ABBOTT QUICKSTART ALKA PHOSPHATASE (ALP) ITEM#5A38
K913921
Em Diagnostic Systems, Inc.
Chemistry · 80d
Cleared Apr 12, 1991
SYSTEMATE ALKALINE PHOSPHATASE(EPOS APPL) #65483
K910639
Em Diagnostic Systems, Inc.
Chemistry · 58d
Cleared Jul 17, 1990
ROCHE COBAS READY ALKALINE PHOSPHATASE REAGENT
K902560
Roche Diagnostic Systems, Inc.
Chemistry · 36d
Cleared Oct 31, 1989
SYSTEMATE(TM) ALKALINE PHOSPHATASE ITEM #65402
K895250
Em Diagnostic Systems, Inc.
Chemistry · 71d
Cleared Mar 24, 1989
ABBOTT CLINICAL CHEMISTRY REAGENT ALP
K890521
Abbott Laboratories
Chemistry · 50d
Cleared Nov 10, 1988
ALKALINE PHOSPHATASE TEST (ALP) ITEM NO. 65651
K884549
Em Diagnostic Systems, Inc.
Chemistry · 10d
Cleared Oct 29, 1987
EASY-TEST ALKALINE PHOSPHATASE (ALP) #19021
K873635
Em Diagnostic Systems, Inc.
Chemistry · 50d
Cleared Sep 29, 1987
ALKALINE PHOSPHATASE (ALK P) TESTPACK #67690/95
K873681
Em Diagnostic Systems, Inc.
Chemistry · 15d
Cleared Feb 06, 1986
EASY-TEST ALKALINE PHOSPHATASE (ALP) REAGENT
K860134
Em Diagnostic Systems, Inc.
Chemistry · 23d
Cleared Jan 29, 1985
VISION -FORMERLY PDA- ALKALINE PHOSPHATASE
K850110
Abbott Laboratories
Chemistry · 15d
Cleared Sep 13, 1984
SYSTEMATE ALKALINE PHOSPHATASE-67203
K843270
Em Diagnostic Systems, Inc.
Chemistry · 24d
Cleared Nov 22, 1982
DIAGNOSTICS ALKALINE PHOSPHATASE OPTIMI
K823213
Boehringer Mannheim Corp.
Chemistry · 25d

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 →