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

Igg (Fc Fragment Specific), Antigen, Antiserum, Control

21 CFR 866.5530 / Immunology
FDA source (opens on fda.gov)

DAS is the FDA product code for Igg (Fc Fragment Specific), Antigen, Antiserum, Control, a class I device type, regulated under 21 CFR 866.5530. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DAS
Device name
Igg (Fc Fragment Specific), Antigen, Antiserum, Control
Regulation
21 CFR 866.5530
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
8
Ingested recalls
0

Clearances, product code DAS

By decision year
8 clearances under product code DAS with a decision year between 1976 and 1998, 1994 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code DAS by decision year
YearClearances
19761
19792
19891
19943
19981

Applicants with the most clearances

Product code DAS
Applicants holding the most 510(k) clearances under product code DAS
ApplicantClearances
Research Diagnostics, Inc.3
Kent Laboratories, Inc.2
Inova Diagnostics, Inc.1
Supelco, Inc.1
The Binding Site1

Companies listing this code with FDA

Companies whose registered establishments list this code