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

Carbonic Anhydrase C, Antigen, Antiserum, Control

21 CFR 866.5200 / Immunology
FDA source (opens on fda.gov)

DDE is the FDA product code for Carbonic Anhydrase C, Antigen, Antiserum, Control, a class I device type, regulated under 21 CFR 866.5200. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DDE
Device name
Carbonic Anhydrase C, Antigen, Antiserum, Control
Regulation
21 CFR 866.5200
Device class
Class I
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
3
Ingested recalls
0

Clearances, product code DDE

By decision year
3 clearances under product code DDE with a decision year between 1982 and 1990, 1982 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code DDE by decision year
YearClearances
19821
19831
19901

Applicants with the most clearances

Product code DDE
Applicants holding the most 510(k) clearances under product code DDE
ApplicantClearances
Siemens Healthcare Diagnostics Inc.2
Syva Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code DDE.