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

Igm, Peroxidase, Antigen, Antiserum, Control

21 CFR 866.5550 / Immunology
FDA source (opens on fda.gov)

DEY is the FDA product code for Igm, Peroxidase, Antigen, Antiserum, Control, a class II device type, regulated under 21 CFR 866.5550. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DEY
Device name
Igm, Peroxidase, Antigen, Antiserum, Control
Regulation
21 CFR 866.5550
Device class
Class II
Review panel
Immunology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
3
Ingested recalls
0

Clearances, product code DEY

By decision year
3 clearances under product code DEY with a decision year between 1992 and 1993, 1992 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code DEY by decision year
YearClearances
19922
19931

Applicants with the most clearances

Product code DEY
Applicants holding the most 510(k) clearances under product code DEY
ApplicantClearances
Ventana Medical Systems Inc3

Companies listing this code with FDA

Companies whose registered establishments list this code