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

Albumin, Fitc, Antigen, Antiserum, Control

21 CFR 866.5040 / Immunology
FDA source (opens on fda.gov)

DDZ is the FDA product code for Albumin, Fitc, Antigen, Antiserum, Control, a class II device type, regulated under 21 CFR 866.5040. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
DDZ
Device name
Albumin, Fitc, Antigen, Antiserum, Control
Regulation
21 CFR 866.5040
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
4
Ingested recalls
1

Clearances, product code DDZ

By decision year
4 clearances under product code DDZ with a decision year between 1983 and 2005, 1983 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code DDZ by decision year
YearClearances
19831
20001
20031
20051

Applicants with the most clearances

Product code DDZ
Applicants holding the most 510(k) clearances under product code DDZ
ApplicantClearances
Dako Corp.1
Good Biotech Corp.1
Horiba Instruments Incorporated1
Randox Laboratories, Limited1

Companies listing this code with FDA

Companies whose registered establishments list this code