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

Azo Dye, Calcium

21 CFR 862.1145 / Clinical Chemistry
FDA source (opens on fda.gov)

CJY is the FDA product code for Azo Dye, Calcium, a class II device type, regulated under 21 CFR 862.1145. As of , FDA records hold 47 510(k) clearances under this code, the most recent dated , and 10 recalls.

Classification record

Product code
CJY
Device name
Azo Dye, Calcium
Regulation
21 CFR 862.1145
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
47
Ingested recalls
10

Clearances, product code CJY

By decision year
47 clearances under product code CJY with a decision year between 1976 and 2025, 1989 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code CJY by decision year
YearClearances
19761
19772
19811
19884
19896
19902
19921
19943
19951
19962
19986
20011
20022
20041
20051
20062
20072
20082
20091
20121
20131
20151
20181
20191
20251

Applicants with the most clearances

Product code CJY
Applicants holding the most 510(k) clearances under product code CJY
ApplicantClearances
Harleco4
Abbott Medical2
Data Medical Associates, Inc.2
Horiba Abx SAS2
Hichem Diagnostics2
Ortho-Clinical Diagnostics, Inc.2
Randox Laboratories, Limited2
Sigma Diagnostics, Inc.2
Abbott Ireland1
Abbott Mfg., Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 21 companies shown, in name order