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

Igm (Mu Chain Specific), Antigen, Antiserum, Control

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

DAO is the FDA product code for Igm (Mu Chain Specific), Antigen, Antiserum, Control, a class II device type, regulated under 21 CFR 866.5550. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DAO
Device name
Igm (Mu Chain Specific), 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
8
Ingested recalls
0

Clearances, product code DAO

By decision year
8 clearances under product code DAO with a decision year between 1979 and 2004, 1979 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code DAO by decision year
YearClearances
19791
19801
19811
19841
19851
19961
19981
20041

Applicants with the most clearances

Product code DAO
Applicants holding the most 510(k) clearances under product code DAO
ApplicantClearances
Advanced Cardiovascular Systems, Inc.1
Applications Lab1
Boehringer Mannheim Corp.1
Dako Corp.1
Electro-Nucleonics Laboratories, Inc.1
Helena Laboratories, Corp.1
Kent Laboratories, Inc.1
Roche Diagnostics GmbH1

Companies listing this code with FDA

Companies whose registered establishments list this code