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

Alpha-2-Macroglobulin, Fitc, Antigen, Antiserum, Control

21 CFR 866.5620 / Immunology
FDA source (opens on fda.gov)

DDY is the FDA product code for Alpha-2-Macroglobulin, Fitc, Antigen, Antiserum, Control, a class II device type, regulated under 21 CFR 866.5620. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
DDY
Device name
Alpha-2-Macroglobulin, Fitc, Antigen, Antiserum, Control
Regulation
21 CFR 866.5620
Device class
Class II
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
1
Ingested recalls
0

Clearances, product code DDY

By decision year
1 clearance under product code DDY with a decision year between 1979 and 1979, 1979 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code DDY by decision year
YearClearances
19791

Applicants with the most clearances

Product code DDY
Applicants holding the most 510(k) clearances under product code DDY
ApplicantClearances
Kent Laboratories, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code