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

Radioassay, Vitamin B12

21 CFR 862.1810 / Clinical Chemistry
FDA source (opens on fda.gov)

CDD is the FDA product code for Radioassay, Vitamin B12, a class II device type, regulated under 21 CFR 862.1810. As of , FDA records hold 78 510(k) clearances under this code, the most recent dated , and 12 recalls.

Classification record

Product code
CDD
Device name
Radioassay, Vitamin B12
Regulation
21 CFR 862.1810
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
78
Ingested recalls
12

Clearances, product code CDD

By decision year
78 clearances under product code CDD with a decision year between 1976 and 2024, 1983 the highest year at 7.
Show the numbers
510(k) clearances under FDA product code CDD by decision year
YearClearances
19762
19772
19782
19794
19803
19813
19821
19837
19842
19853
19862
19881
19901
19912
19922
19932
19941
19952
19962
19975
19992
20021
20042
20051
20063
20071
20091
20101
20113
20123
20131
20142
20151
20162
20171
20192
20221
20241

Applicants with the most clearances

Product code CDD
Applicants holding the most 510(k) clearances under product code CDD
ApplicantClearances
Siemens Healthcare Diagnostics Inc.14
Axis-Shield Diagnostics, Ltd.6
Abbott Medical4
Ciba Corning Diagnostics Corp.4
BD Becton Dickinson Vacutainer Systems Preanalytic3
Bio-Rad3
Corning Medical & Scientific3
Ria Products, Inc.3
Bio-Rad Laboratories Inc.2
Boehringer Mannheim Corp.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 26 companies shown, in name order