510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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CJEClass II

Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes

21 CFR 862.1050 / Clinical Chemistry
FDA source (opens on fda.gov)

CJE is the FDA product code for Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes, a class II device type, regulated under 21 CFR 862.1050. As of , FDA records hold 124 510(k) clearances under this code, the most recent dated , and 22 recalls.

Classification record

Product code
CJE
Device name
Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Regulation
21 CFR 862.1050
Device class
Class II
Review panel
Clinical Chemistry
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
124
Ingested recalls
22

Clearances, product code CJE

By decision year
124 clearances under product code CJE with a decision year between 1976 and 2025, 1986 the highest year at 11.
Show the numbers
510(k) clearances under FDA product code CJE by decision year
YearClearances
19766
19779
19785
19792
19804
19814
19823
19834
19846
19855
198611
19876
19886
19892
19905
19913
19924
19932
19942
19952
19961
19973
19984
19993
20003
20012
20022
20031
20061
20081
20112
20121
20132
20172
20181
20191
20231
20241
20251

Applicants with the most clearances

Product code CJE
Applicants holding the most 510(k) clearances under product code CJE
ApplicantClearances
Em Diagnostic Systems, Inc.10
Abbott Medical5
Harleco5
J.T. Baker Chemical Co.4
Sigma Diagnostics, Inc.4
Data Medical Associates, Inc.3
American Research Products Co.2
Beckman Instruments, Inc.2
Bio-Analytics Laboratories, Inc.2
Sekisui Diagnostics P.E.I. Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 29 companies shown, in name order