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

Prealbumin, Fitc, Antigen, Antiserum, Control

21 CFR 866.5060 / Immunology
FDA source (opens on fda.gov)

DDS is the FDA product code for Prealbumin, Fitc, Antigen, Antiserum, Control, a class I device type, regulated under 21 CFR 866.5060. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DDS
Device name
Prealbumin, Fitc, Antigen, Antiserum, Control
Regulation
21 CFR 866.5060
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
4
Ingested recalls
0

Clearances, product code DDS

By decision year
4 clearances under product code DDS with a decision year between 1986 and 1997, 1997 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code DDS by decision year
YearClearances
19861
19941
19972

Applicants with the most clearances

Product code DDS
Applicants holding the most 510(k) clearances under product code DDS
ApplicantClearances
Beckman Instruments, Inc.2
Hemagen Diagnostics, Inc.1
Incstar Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code