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

Haptoglobin, Antigen, Antiserum, Control

21 CFR 866.5460 / Immunology
FDA source (opens on fda.gov)

DAD is the FDA product code for Haptoglobin, Antigen, Antiserum, Control, a class II device type, regulated under 21 CFR 866.5460. As of , FDA records hold 18 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
DAD
Device name
Haptoglobin, Antigen, Antiserum, Control
Regulation
21 CFR 866.5460
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
18
Ingested recalls
1

Clearances, product code DAD

By decision year
18 clearances under product code DAD with a decision year between 1976 and 1999, 1987 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code DAD by decision year
YearClearances
19761
19771
19801
19811
19831
19841
19851
19873
19891
19911
19921
19951
19961
19971
19981
19991

Applicants with the most clearances

Product code DAD
Applicants holding the most 510(k) clearances under product code DAD
ApplicantClearances
Applications Lab1
Atlantic Antibodies1
Beckman Instruments, Inc.1
Behring Diagnostics, Inc.1
Boehringer Mannheim Corp.1
Cooper Biomedical, Inc.1
Crestat Diagnostics, Inc.1
Dako Corp.1
Instrumentation Laboratory Co.1
J.T. Baker Chemical Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 22 companies shown, in name order