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

Ceruloplasmin, Antigen, Antiserum, Control

21 CFR 866.5210 / Immunology
FDA source (opens on fda.gov)

DDB is the FDA product code for Ceruloplasmin, Antigen, Antiserum, Control, a class II device type, regulated under 21 CFR 866.5210. As of , FDA records hold 19 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DDB
Device name
Ceruloplasmin, Antigen, Antiserum, Control
Regulation
21 CFR 866.5210
Device class
Class II
Review panel
Immunology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
19
Ingested recalls
0

Clearances, product code DDB

By decision year
19 clearances under product code DDB with a decision year between 1977 and 2017, 1979 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code DDB by decision year
YearClearances
19771
19782
19793
19801
19811
19821
19853
19861
19891
19911
19971
20061
20131
20171

Applicants with the most clearances

Product code DDB
Applicants holding the most 510(k) clearances under product code DDB
ApplicantClearances
Kent Laboratories, Inc.3
Beckman Instruments, Inc.2
Kallestad Laboratories, Inc.2
Beckman Coulter Ireland Inc1
Behring Diagnostics, Inc.1
Cooper Biomedical, Inc.1
Siemens Healthcare Diagnostics Inc.1
Dako Corp.1
Hyland Therapeutic Div., Travenol Laboratories1
Icl Scientific1

Companies listing this code with FDA

Companies whose registered establishments list this code