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

Saccharogenic, Amylase

21 CFR 862.1070 / Clinical Chemistry
FDA source (opens on fda.gov)

CIJ is the FDA product code for Saccharogenic, Amylase, a class II device type, regulated under 21 CFR 862.1070. As of , FDA records hold 31 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
CIJ
Device name
Saccharogenic, Amylase
Regulation
21 CFR 862.1070
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
31
Ingested recalls
1

Clearances, product code CIJ

By decision year
31 clearances under product code CIJ with a decision year between 1976 and 2002, 1986 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code CIJ by decision year
YearClearances
19762
19782
19792
19812
19842
19851
19865
19875
19891
19932
19942
19951
19961
19981
19991
20021

Applicants with the most clearances

Product code CIJ
Applicants holding the most 510(k) clearances under product code CIJ
ApplicantClearances
Harleco4
Behring Diagnostics, Inc.2
Biotrol, USA, Inc.2
Coulter Electronics, Inc.2
Data Medical Associates, Inc.2
Em Diagnostic Systems, Inc.2
Horiba Instruments Incorporated2
Ac Biochemicals, Inc.1
American Dade1
Bayer Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code