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

Radioimmunoassay, Testosterones And Dihydrotestosterone

21 CFR 862.1680 / Clinical Chemistry
FDA source (opens on fda.gov)

CDZ is the FDA product code for Radioimmunoassay, Testosterones And Dihydrotestosterone, a class I device type, regulated under 21 CFR 862.1680. As of , FDA records hold 89 510(k) clearances under this code, the most recent dated , and 19 recalls.

Classification record

Product code
CDZ
Device name
Radioimmunoassay, Testosterones And Dihydrotestosterone
Regulation
21 CFR 862.1680
Device class
Class I
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
89
Ingested recalls
19

Clearances, product code CDZ

By decision year
89 clearances under product code CDZ with a decision year between 1978 and 2026, 1980 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code CDZ by decision year
YearClearances
19782
19792
19806
19814
19832
19843
19854
19862
19872
19881
19891
19901
19912
19924
19932
19942
19953
19963
19972
19982
20004
20024
20033
20041
20061
20071
20091
20102
20112
20121
20131
20141
20152
20164
20181
20194
20201
20221
20231
20242
20261

Applicants with the most clearances

Product code CDZ
Applicants holding the most 510(k) clearances under product code CDZ
ApplicantClearances
Siemens Healthcare Diagnostics Inc.18
Diagnostic Systems Laboratories, Inc.7
Leeco Diagnostics, Inc.4
Roche Diagnostics GmbH4
Abbott Medical3
Immunodiagnostic Systems Ltd.3
Qualigen Inc3
Biokit, S.A.2
Cambridge Medical Technology2
Diasorin Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 46 companies shown, in name order