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

Alpha-1-T-Glycoprotein, Antigen, Antiserum, Control

21 CFR 866.5420 / Immunology
FDA source (opens on fda.gov)

DEN is the FDA product code for Alpha-1-T-Glycoprotein, Antigen, Antiserum, Control, a class I device type, regulated under 21 CFR 866.5420. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DEN
Device name
Alpha-1-T-Glycoprotein, Antigen, Antiserum, Control
Regulation
21 CFR 866.5420
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
2
Ingested recalls
0

Clearances, product code DEN

By decision year
2 clearances under product code DEN with a decision year between 1977 and 1978, 1977 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code DEN by decision year
YearClearances
19771
19781

Applicants with the most clearances

Product code DEN
Applicants holding the most 510(k) clearances under product code DEN
ApplicantClearances
Hyland Therapeutic Div., Travenol Laboratories1
Icl Scientific1

Companies listing this code with FDA

Companies whose registered establishments list this code

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